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2 weeks ago

Strategic Quality Partner

Roche - Carlsbad, CA 92008

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche is strongly committed to an inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing inclusion and belonging enables us to create a great place to work and to innovate for patients. The Strategic Quality Partner acts as a single point of contact within project teams (New product development / Product Change) for a portfolio of products assigned to them. The SQP leads and drives for decisions for strategic topics from a compliance and product quality perspective. The SQP partners with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings. Stakeholders include, but are not limited to Development Leads, Project Leaders, Regulatory Affairs, Operations, Global Customer Support, and Post-Market Quality. The Opportunity • Ensure consistent interpretation& implementation of global requirements across Customer Areas (CAs) • Incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support and ensure PostMarket Quality feedback is built into the requirements • Ensure development project plans contain the right deliverables according to the Design& Development module to deliver safe and compliant solutions • Support internal and external audits • Lead and facilitate constructive discussions e.g. at project team meetings • Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality& Regulatory decision making; prepare and enable risk-based decisions • Partner to ensure effective resolution of issues (e.g. CAPA, NC) • Ensure effective feedback loops and information flow for milestone review. Who You Are • Bachelor's degree in science, engineering, business administration or a related field. MBA or advanced degree is considered an advantage. • 8+ years of experience in the diagnostics industry or a related field in business related functions • Strong scientific and technical background with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD Products. • Strong business and financial acumen with an enterprise mindset • Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, ISO 14971, GDP, GMP, others) • Excellent communication, presentation, and negotiation skills. • Strong agile knowledge and capabilities demonstrating new ways of working • Pragmatic decision making and ability to move forward without a perfect solution • Demonstrated thorough E2E understanding for lifecycle management • Strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change. Locations You are located in Carlsbad, CA. This is a primarily onsite role. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of Carlsbad is $103,800 and $221,780. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Who we are GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California. GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this formAccommodations for Applicants.

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2 weeks ago

Senior Quality Engineer

Nucleus Biologics - San Diego, CA 92127

About Nucleus Biologics: At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. About the role The Senior Quality Engineer is responsible for ensuring compliance with regulatory requirements (i.e. ISO 9001, ISO 13485, and EXCiPACT) and internal quality standards. This role leads the Environmental Monitoring and Stability programs, provides critical support for Aseptic Process Validation and Process/Equipment Validation activities, and drives Operational Excellence initiatives. The Senior Quality Engineer works cross-functionally to uphold the highest standards of product quality and continuous improvement. The ideal candidate for this role will be willing to be 100% onsite and work a flexible schedule that allows for coverage in the afternoon/evenings to support critical manufacturing runs. The ideal candidate for this role will be willing to be 100% onsite and work a flexible schedule that allows for coverage in the afternoon/evenings to support critical manufacturing runs. What you'll do RESPONSIBILITIES: Stability Program Oversight Manage the end-to-end stability program, including onboarding new studies, maintaining the stability schedule, and ensuring timely execution of all stability protocols. Author and review stability study protocols, ensuring alignment with regulatory requirements and product-specific objectives. Ensure the timely completion of stability testing by coordinating with internal and external testing needs. Review stability data and results throughout the study lifecycle, identifying trends and flagging out-of-trend or out-of-specification results for investigation. Complete interim and final stability reports as required, ensuring accuracy, completeness, and regulatory compliance. Maintain stability program documentation within the Quality Management System (QMS). Aseptic Process Validation Support Support aseptic process validation (APV) activities, including Media Fills and related studies, in collaboration with the Validation and Manufacturing teams. Author and review APV protocols, ensuring scientific rigor and alignment with current regulatory guidance (e.g., FDA Aseptic Processing Guidance, Annex 1). Conduct thorough review of executed APV protocols, verifying data integrity and compliance with acceptance criteria. Generate and finalize APV summary reports, ensuring all deviations, investigations, and conclusions are appropriately documented. Serve as the Quality point of contact for aseptic process validation inquiries and regulatory submissions as needed. Process & Equipment Validation Support Collaborate cross-functionally with the Validation team to support the creation, review, and routing of process and equipment validation protocols and reports. Provide Quality oversight and approval for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation. Ensure validation activities align with applicable regulatory requirements, internal SOPs, and industry best practices. Participate in risk assessments and validation planning activities to prioritize and scope validation efforts appropriately. Support the resolution of validation-related deviations and contribute to continuous improvement of the validation program. Environmental Monitoring Execute and support Environmental Monitoring (EM) program in accordance with established protocols and regulatory requirements. This includes routing EM, personnel monitoring and water sampling. Assist with the review and analysis of EM, personnel monitoring, and water testing data to identify trends, adverse events, and opportunities for improvement. Assist with investigations related to EM excursions, initiating appropriate corrective actions as needed. Product Release Support Review batch records, manufacturing documentation, and associated data to ensure accuracy, completeness, and compliance with established procedures and regulatory requirements. Support the execution and/or review of Quality Control related activities necessary for raw material and finished good releases. Operational Excellence Conduct analyses of existing quality and business processes to identify inefficiencies, bottlenecks, and areas for improvement. Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing operational efficiency and effectiveness. Partner with senior leadership to align Operational Excellence initiatives with strategic business objectives and priorities. Develop and monitor key performance indicators (KPIs) to demonstrate and communicate the results of improvement initiatives. Support the development and delivery of training related to quality processes and improvement activities. Qualifications EDUCATION: Bachelor’s degree in Life Sciences, Microbiology, Biology, or a related field. A combination of education and/or relevant job experience may be considered. REQUIRED EXPERIENCE: 5-7 years of experience within the pharmaceutical, biotechnology, or related regulated industry. Experience with environmental monitoring, water testing, and microbiological/chemical testing methodologies preferred. Including familiarity with gowning practices to execute processes within an ISO 5 and ISO 7 environment. Strong organizational skills with attention to detail and the ability to manage multiple tasks. Experience managing stability programs, including protocol authorship, study execution oversight, and report generation. Familiarity with Aseptic Process Validation (e.g., Media Fill programs) and process/equipment qualification activities (IQ/OQ/PQ). Strong knowledge of GMP, ISO (9001/13485), USP standards and applicable regulatory requirements related to EM, stability, and validation. Ability to execute routine testing such as pH, Conductivity, Endotoxin, Density, Osmolality and Appearance. Experience with Quality Management Systems (QMS) and electronic documentation platforms. Excellent problem-solving, analytical, and organizational skills with a high attention to detail. Strong communication and leadership abilities, with experience collaborating across cross-functional teams. ADDITIONAL SKILLS: Ability to independently develop and manage projects and timelines Familiarity with the execution of Celsis testing is a plus PHYSICAL REQUIREMENTS: Ability to hear and speak to employees and external associates on the phone and in person. Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions [for manufacturing positions only] Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis. TRAVEL REQUIREMENTS: May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position. NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.

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2 weeks ago

Production Chemist

QuidelOrtho Corporation - San Diego, CA 92121

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Production Chemist. Under minimal ongoing supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP under the direction of senior staff including manufacturing products within QSR and ISO regulations This position will be onsite in San Diego, CA. The Responsibilities Carries out production tasks in support of manufacturing goals and objectives Participates in Lean Initiatives Operates laboratory equipment safely, as trained and directed, in accordance with established practices Maintains records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system Ensures materials are appropriately labeled, approved for use and in sufficient quantity to complete required tasks Reviews/reconciles documents and work orders. Writes/revises documentation as needed Supports product transfers May Train other chemists/lab technicians Partners with the planners, provide input into weekly schedule Initiates and participates in lead document revisions to ensure accurate BOM's process descriptions, NCMR and deviations Operates laboratory equipment and perform routine maintenance/repair Follows all safety guidelines, manufacturing policies and procedures. Operate under strict QSR and ISO compliance Performs complex formulations, component and material evaluations, equipment calibrations and maintenance Formulates complex chemistries and solutions as directed, following established guidelines and procedures Carries out duties in compliance with established business policies Performs other duties & projects as assigned Participates in product/process troubleshooting and validations Carries out functions which may require multiple task coordination Covers on call assignment and complies with all restrictions and requirements Assesses issues affecting departmental performance, Quality standards, and product quality Individually communicates to management and initiates appropriate corrective action Supports departmental troubleshooting, cross-functional projects and process improvement teams Perform other work-related duties as assigned The Individual Required: High School Diploma plus 5-8 years of related work experience in a GMP environment, or BA or BS in Chemistry, Biological Sciences, and 2-4 years of related experience in a GMP environment, or Master’s degree in Chemistry, Biological Sciences, or equivalent and 0-2 years of related experience in GMP environment required Ability to follow detailed instructions, maintains accurate records and notes, and carries out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices Knowledge of a variety of lab equipment and their operation Ability to carry out experiments following established guidelines and summarize results accurately Strong problem-solving and troubleshooting skills Strong verbal and written communication skills Organized and detail oriented Ability to work in a team environment General computer knowledge Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities This position is not currently eligible for visa sponsorship. Preferred: Previous training and experience in the operation of lab equipment and use of lab chemicals and tools preferred. The Key Working Relationships Internal Partners: Manufacturing, Materials, Technical Support and Quality Assurance The Work Environment The work environment characteristics are representative of an office, laboratory, and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. The Physical Demands Position requires ability to lift up to 30 lbs. on a regular basis. Up to 75% of time at lab or production environment, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $67,303.53 - $75,000.00 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com . #LI-HF1

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2 weeks ago

Electrical Manufacturing Engineer – Contract Manufacturing

Hunter Industries - San Marcos, CA 92078

Hunter Industries is seeking an Electrical Manufacturing Engineer to join our Contract Manufacturing team! In this role you will identify and implement manufacturing processes, procedures, and projects focused on minimizing product cost, improving product quality, and maintaining product availability for assigned product lines. You will work on projects across multiple departments that are aligned with the organization’s strategic objectives. *We are considering all skill levels for this role. If you are unsure if you qualify and don't check all the boxes, or check them all and then some, we encourage you to apply! Essential Functions: Responsible for the resolution of manufacturing issues of assigned product lines that affect product quality and/or availability. Develops and coordinates the necessary processes and sustaining engineering protocols to ensure manufacturing operational efficiencies. Maintains manufacturing-related documentation and production reports that define key metrics and outline current activities. Uses lean manufacturing practices and Six Sigma methodology to evaluate and improve assembly line performance per established key performance indicators. Implements improvement processes to ensure that projects are justifiable, on schedule and within budget. Provides manufacturing engineering support for complete integration of new products into full production per the organization’s New Product Development and Introduction (NPDI) process. Provides focus on delivering a repeatable process with high quality yield. Supports the concurrent engineering effort on behalf of manufacturing as a member of the product development team. Maintains updated capacity models for both injection molds and assembly equipment for assigned product lines. Submits capital requests as required to ensure timely completion of equipment to meet forecasted production. Provides capital requirements for annual budgeting process. Leads or supports cost reduction projects including qualification of new vendors for materials or parts. Participates in test plan development and execution. Evaluates current products, production lines, and processes to pinpoint areas for improvement, and submits recommendations for review. Develops BOMs, test procedures and other related documentation required to support new products. Works with various departments to transfer new designs into production. Supports Incoming Inspection and Warranty Test by providing technical support for failure analysis. Works with Engineering to prioritize product improvements based on trend analysis. Education/Training Required and Preferred: Bachelor’s degree in Electrical Engineering is required. Experience Required and Preferred: 2+ years of engineering experience within a manufacturing organization. Experience working with electromechanical products is preferred. What You Bring: Knowledge of business and management principles involved in strategic planning, resource allocation, production methods, and coordination of people and resources. Knowledge of the practical application of engineering science and technology. This includes the knowledge of LEAN Manufacturing & Six-Sigma methodology techniques and how it can be applied in the manufacturing environment. Ability to speak and write effectively as appropriate for the needs of the audience. Excellent written and verbal communication skills in English, with strong report-writing and presentation skills. Strong computer knowledge including several Microsoft Office programs. Logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Excellent attention to detail, organizational and time management skills, and the ability to work within timelines. Excellent judgment and decision-making skills, with the ability to consider the relative costs and benefits of potential actions to choose the most appropriate one. Ability to travel domestically and internationally and work flexible hours to visit supplier facilities worldwide. Ability to obtain a valid passport, if necessary. Experience with electronics assembly and injection molded plastic components preferred. Knowledge of SPC, FMEA, DOE and process capability studies preferred. Experience with irrigation products or industry preferred. What We Offer: Amazing corporate culture - we walk the walk when it comes to our values! Beautiful 20 acre park like campus with creek and walking trails On site wellness center with personal training, fitness classes and massage FUN company events! Company donation matching and volunteer rewards Career development opportunities and profit sharing bonus Follow us on LinkedIn, check out our rave reviews on Glassdoor, and learn more about our company culture on our career site: http://corporate.hunterindustries.com/careers Hunter is a global leader in the irrigation, outdoor lighting, dispensing technology, and custom manufacturing industries. Driving our continued success is the combined energy and talents of the nearly 4,000 people on our team. Together, we create a diverse array of products that can be seen all over the world, from residential landscapes to national landmarks, stadiums, parks, hotels, and municipal buildings. Hunter Industries and its Family of Companies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability, gender, gender identity or expression, military and veteran status, national origin, race, religion, sexual orientation, or any other applicable legally protected status or characteristic. The salary for this opportunity ranges from $80,000 - $115,000 The Company complies with all federal/local/state regulations in regard to pay. The above represents the expected salary range for this job requisition. Compensation offered to the successful candidate will be determined by qualifications, prior experience, other job-related factors, and geographic location.

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2 weeks ago

Quality Engineer, Hi-Rel

Blue Marble Communications - Poway, CA 92064

The Quality Engineer (QE) will be responsible for product compliance with internal and customer requirements. These spans conception to completion. In addition, the QE will develop, coordinate, improve, evaluate, and maintain the quality assurance program. Prior quality assurance experience and familiarity with industry standards (e.g. J-STD-001, IPC-A-600, IPC-A-610, IPC/WHMA-A-620, ISO9001, AS9100) is required. The QE must have an aptitude and eagerness to learn, speak up when problems arise, and follow the process. They must be a self-starter with great time management skills and very strong attention to detail. Responsibilities Inspect PCBs, PCBAs, machined parts, mechanical assemblies, cable assemblies, optical assemblies, and sub-assemblies, as necessary Read and confirm compliance to Assembly Drawings, Bill of Materials (BOMs), Wire List, Engineering Drawings, Change Orders, and Rework Instructions Use of calipers, go/no go gages, microscopes, torque drivers, micrometers, digital multimeters, etc. as needed for ensure product compliance Identify and segregate nonconforming items per the internal process Validate test stations are configured, as required, per test procedures Witness testing and provide oversight to ensure compliance to requirements Generate First Article Inspection Reports (FAIRs) per AS9102 Audit the quality system for compliance and implement actions to address non-conformances Generate and evaluate quality metrics to identify issues/trends and implement corrective/preventive actions to address nonconformances Manage Corrective and Preventive Action (CAPA) Requests, Nonconforming Material Reports (NCMRs), etc. Participate in design reviews and review/approve documentation change orders Recommend procedural or manufacturing process changes for continuous improvement Prepares statistical analysis reports, specifications, and other technical documents. Generate End Item Data Packages (EIDPs) and support Customer Source Inspection (CSI) Facilitate Manufacturing Review Boards (MRBs) and Failure Review Boards (FRBs) Interface with external customers Qualifications Bachelor's Degree preferred or 5+ years of experience J-STD-001, IPC-A-610, and/or WHMA/IPC-A-620 certifications a plus Familiarity with calipers, go/no gages, microscopes, torque drivers, micrometers, etc. Basic understanding of Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 Familiarity with AS9100/ISO 9001 Quality Management Systems The ability to read engineering drawings, specifications, statements of work, and contracts Effective communication skills with all levels of the organization Close attention to detail and the ability to work independently or with a team Excellent MS Office skills and a willingness to travel, if required Must be a US Person (This position has export control and security-related requirements that mandate attention to the citizenship status of any potential candidate and necessitates that the individual either be a United States Citizen, Permanent Resident of the United States, or lawfully admitted into the United States as a refugee or granted asylum by the United States Government.) About Blue Marble Communications Blue Marble Communications designs and manufactures high-performance RF, free-space optical, and network communications modules and systems for deployment onboard satellites and other space vehicles. Our current product offerings include software-defined RF, microwave, and millimeter-wave modem/transceivers; optical laser communications terminals, Ethernet routers/switches, and systems comprised of combinations of these modules. BMC embraces a modern workplace culture and inclusive environment.

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2 weeks ago

Production Operator

PrideStaff Carlsbad - Oceanside, CA 92056

Production Operator Join our dynamic team in Oceanside, CA, 92056, as a Production Operator! We are looking for motivated individuals who thrive in a fast-paced environment and are eager to contribute to our production processes. If you have a keen eye for detail and a passion for quality, we want to hear from you! Overview As a Production Operator, you will play a crucial role in our manufacturing operations. You will be responsible for ensuring that our production lines run smoothly and efficiently while maintaining the highest standards of quality. This is an excellent opportunity to grow your skills in a supportive and innovative workplace. Responsibilities Operate and monitor production equipment to ensure optimal performance. Follow standard operating procedures and safety guidelines to maintain a safe work environment. Conduct quality checks on products to ensure compliance with specifications. Assist in troubleshooting and resolving equipment issues as they arise. Maintain accurate production records and documentation. Collaborate with team members to meet production goals and deadlines. Participate in training and development programs to enhance skills and knowledge. Qualifications High school diploma or equivalent; additional technical training is a plus. Previous experience in a manufacturing or production environment is preferred. Strong attention to detail and commitment to quality. Ability to work effectively in a team-oriented environment. Basic mechanical skills and problem-solving abilities. Willingness to work flexible hours, including overtime if necessary. Good communication skills and a positive attitude.

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2 weeks ago

Production Worker

Hot Shoppe Designs, Inc. - San Clemente, CA 92673

Hot Shoppe Designs is Hiring Manufacturing / Production Team Member Hot Shoppe Designs, a custom apparel manufacturer in San Clemente, is looking for a reliable, hardworking person to join our production team. Experience is helpful, but we are willing to train the right person. If you have a good attitude, show up on time, pay attention to detail, and are willing to learn, this could be a great opportunity. This position will include working with fabric, assisting with digital cutting equipment, trimming and packaging finished garments, helping maintain a clean work area, and supporting our production team with day-to-day manufacturing tasks. Job Duties May Include: Operating and assisting with digital cutting equipment Loading and aligning fabric rolls onto cutting tables Checking finished pieces for accuracy, logos, colors, and quality Helping trim, organize, and package garments Keeping work areas and equipment clean and organized Assisting with basic machine maintenance and setup Working with the production team to complete jobs efficiently Following safety procedures and company guidelines What We’re Looking For: Reliable and punctual Strong attention to detail Willingness to learn Able to work in a busy production environment Comfortable standing for long periods of time Able to lift, push, pull, or carry up to 40 lbs. as needed Prior production or manufacturing experience is a plus, but not required English/Spanish is a plus Schedule: Monday through Friday 7:30 a.m. to 4:00 p.m. 30-minute lunch Pay: $18.50 to $20.00 per hour, depending on experience Benefits: Six Paid Holidays, Five Days Advanced Sick Time How to Apply: Please email your work experience, the city you live in, and your contact information. We are looking to hire as soon as possible. Pay: $18.50 - $20.00 per hour Work Location: In person

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2 weeks ago

Quality Assurance Specialist II

Catalent Pharma Solutions - San Diego, CA 92121

Quality Assurance Specialist II Position Summary: Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include pre-formulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds. The Quality Assurance Specialist II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements. The Role: Performs pre and post execution batch record review. Authoring/Updating documents related to Material Management Quality Control, Material Management Quality Assurance, Batch Records, Compliance, and Validation Systems. Participates in Investigations and deviation writing. Support client communications. Reviewing /approving change controls and change actions Adhere to GMP standards routinely with limited errors and limited guidance Other duties as assigned. The Candidate: High School Diploma or GED required. Bachelors or Master’s degree in a scientific discipline preferred. High School Diploma with 10+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience. BS with 7+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience. MS with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience. JD Edwards or comparable ERP systems preferred. Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.). Physical Requirements: Frequent standing, walking, and sitting required. Position occasionally requires lifting, pushing, and pulling of up to 35 lbs. Occasional kneeling and reaching required. Pay: The anticipated salary range for this role in California is $85,000 to $89,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement – Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

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2 weeks ago

Senior Quality System Specialist II

Werfen - San Diego, CA 92121

Introduction: Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview: Position Summary: Responsible for the planning, coordination, control, and implementation of continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager. The annual base salary range for this role is currently $120,000 to $150,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. Responsibilities: Key Accountabilities Essential Functions: The Senior QS Specialist II will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for maintenance, improvement and leadership of at least one or two of the following: CAPA process – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate Internal Audit program – planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit. Quality Agreements – maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision Quality Plans – issuing number, creating plan, tracking status, timely/appropriate closure External Documents – tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans. Management Review – Support the creation and delivery of the Management Review presentation. Support completion and approval of the Management Review Meeting Minutes and closure of Action Items. Training program – focusing on improving the competencies of personnel to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed. Secondary Functions: Facilitates and leads meetings related to QS activities Supports and leads change orders/process improvements with respect to Quality Management System procedures with direction from management Develop and maintain a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs Participate in internal, external (including regulatory) and/or 3rd party audits, as needed Carries out duties in compliance with established business policies Provides assistance and recommendations based on a clear understanding and implementation of regulatory standards Interfaces with all functions and levels of management as needed Other duties as assigned, according to the changing needs of the business Networking/Key Relationships: To be determined based on department needs, to include interactions such as: All Werfen Departments Werfen Affiliate QARA Werfen Corporate and other Werfen Manufacturer QARA Qualifications: Minimum Knowledge & Experience Required for the Position: Education: Minimum of bachelor’s degree, in related scientific or technical field Experience: Minimum 10 years (or 7 years with advanced degree) of experience in the medical device, IVD or other regulated industry Additional Skills/Knowledge: Previous Quality Assurance experience within a GMP regulated environment required Strong understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation Strong computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required Lean/Six Sigma experience, or equivalent certification/education/experience is a plus Minimal Leadership Skills required Strong understanding of change control requirements Strong understanding of record retention Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Attention to Detail: Strong Ability to pay close attention to detail is required Accuracy: Work is accurate and completeness of records Outstanding Performance Standards: Demonstrated strong ability to meet department goals Ethics and Values: must demonstrate Integrity and Trust / Ability to be Discrete Delivery of Results (Action Orientation): Strong ability to Learn on the Fly / Taking Initiative Communication: Strong written and verbal communication skills Discretion: Acts Honest, Loyal, Trustworthy Multi-Tasking: Strong planning, organizational and time management skills are required to support changing business needs Collaboration: Strong ability to work with cross functional teams Independence: Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties Takes Initiative: Strong ability to drive continuous improvement, correct deficiencies and to prevent recurrence Problem Solving: Strong problem-solving skills are required Travel Requirements: <5% of time may be required for travel Closing: If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

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2 weeks ago

Sr. Manager, R&D Operations Manager

Pratt & Whitney - Carlsbad, CA 92010

Date Posted: 2026-03-23 Country: United States of America Location: US-CA-CARLSBAD-582 ~ 2752 Loker Ave W ~ LOKER Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. Security Clearance Type: None/Not Required Security Clearance Status: Not Required At RTX, the world largest aerospace and defense company, 185,000 great minds are united by purpose and inspired to make a difference solving the world’s most complex problems. With our three market leading businesses, world-class operations and investments in research and development, we offer capabilities and opportunity no one else can. Together, we push the boundaries of known science and find new ways to connect and protect our world. Pratt & Whitney is a world leader in the design, manufacture and service of aircraft engines and auxiliary power systems and has been revolutionizing modern flight for over 100 years. Join us and help shape the future of aerospace and defense. Pratt & Whitney is working to once again transform the future of flight—designing, building and servicing engines unlike any the world has ever seen. And because transformation begins from within, we’re seeking the people to drive it. So, calling all curious. Come ready to explore and you’ll find a place where your talent takes flight—beyond the borders of title, a country or your comfort zone. Bring your passion and commitment and we’ll welcome you into a tight-knit team that takes our mission personally. Channel your drive to make a difference into shaping an organization and an industry that’s evolving fast to the future. At Pratt & Whitney, the difference you make is on display every day. Just look up. Are you ready to go beyond? What You Will Do: Pratt & Whitney (P&W) is seeking a highly motivated individual to support the manufacturing maturation of ceramic matrix composite (CMC) turbine components. CMCs are an enabling material that increases the temperature capability of jet engine components. Through successful development and application of these materials, P&W will deliver engines that are more fuel efficient, lighter weight and more durable for commercial and military applications. This position will be located in Carlsbad, CA. If you thrive in a fast-paced, dynamic environment and are looking for an opportunity to develop your operations career, then we have a great opportunity for you. We are seeking a motivated, results-oriented R&D Operations Manager to continue to drive our vision at the Ceramic Matrix Composites Center of Excellence. Specific responsibilities for this position include: Direct all manufacturing operations including planning, staffing, training and development, safety and quality compliance, cost management and continuous improvement. Collaborate with the engineering, quality, project and maintenance teams to produce high quality products on schedule and within the cost target Lead the development and implementation of a manufacturing strategy based on lean production and Industry 4.0 principles Support deployment of digital systems to collect and analyze comprehensive process data as part of the digital thread for CMC manufacturing and implementation Qualifications You Must Have: BA/BS degree w/10+ years experience or 7+ years experience with an advanced degree U.S. citizenship is required as only U.S. citizens are authorized to access information under this program/contract. Qualifications We Prefer: 7+ years of related experience in a manufacturing or R&D environment at the managerial level Strong leadership behaviors that emphasize goal setting, team empowerment and providing support Strong background of leading in a fast-paced, high mix manufacturing or R&D operation Strong continuous improvement focus and experience in leading Lean/Six Sigma improvements Prior experience in composites or aerospace is highly desirable Knowledge and effective practice of Environmental, Health and Safety requirements Knowledge and effective practice of aerospace quality practices like ISO9001 AS9100 What We Offer: · Benefits · Relocation Package Learn More & Apply Now! What is my role type? In addition to transforming the future of flight, we are also transforming how and where we work. We’ve introduced role types to help you understand how you will operate in our blended work environment. This role is: Onsite - responsibilities for this job require candidates to work onsite within the manufacturing campus Candidates will learn more about role type and current site status throughout the recruiting process. For onsite and hybrid roles, commuting to and from the assigned site is the employee’s personal responsibility. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 145,600 USD - 276,800 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate’s work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company’s performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act. Privacy Policy and Terms:

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2 weeks ago

Sr Design Quality Engineer

Illumina - San Diego, CA 92122

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary In this cross functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams. Key Responsibilities - Provides Quality oversight to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs throughout the product lifecycle - Provides support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors - Ensures products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems - Leads product risk management activities - Audits the quality and completeness of product Design History Files and/or Device Master Record - Facilitates participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology - Provides management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion - Utilizes quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis) - Other such duties that may be determined by Management Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Experience/Education - Bachelor's Degree in Engineering or Science field with 5+ years of related experience, or Master's Degree with 3+ years of related experience - PhD Engineering and/or Science Degree with 2+ years experience Preferred Qualifications - PhD Engineering and/or Science Degree with 2+ years experience - Quality Certification (e.g. CQE) Upon Hire - Technical expertise in products such as reagents, consumables, assays, instruments preferred - Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis) - Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR preferred - Highly effective communication, facilitation, coaching, and negotiation skills - Adaptable to fast-paced, dynamic work environment with shifting demands - Must be detailed oriented, well organized and able to work independently and in teams The estimated base salary range for the Sr Design Quality Engineer role based in the United States of America is: $90,000 - $135,000. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role. Most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.

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2 weeks ago

Production Planner

Carbon By Design - Vista, CA 92081

PRODUCTION PLANNER JOB DESCRIPTION DEPARTMENT: OPERATIONS MANAGEMENT REPORTS TO: SENIOR MANAGER OF OPERATIONS FLSA STATUS: EXEMPT EMPLOYMENT STATUS: FULL- TIME Position Summary: A production planner is responsible for the accuracy and timeliness of the production process. Duties include a specific focus on the materials and goods required in the production phase. Essential Duties and Responsibilities: Uses (ERP system Epicor and Netsuit and Excel) tools to plan, prepare, issue, and adjust work-in-process to meet customer demands and established inventory targets. Coordinates the preparation and planning of work order releases to support schedules and balance workload. Solves production and priority conflicts and addresses past-due work order problems daily Attends daily production/sales/quality/shortage meetings to answer questions and resolve problems; keeps manufacturing management apprised of said issues. Identifies and solves material and other constraints that prevent the release of work orders. Coordinates, schedules, and priority conflicts in Manufacturing Operations. Reviews production capacity for constraints and works with manufacturing to resolve. Coordinate manufacturing and manufacturing engineering to ensure routing accuracy. Coordinate sales order scheduling Maintains on-time delivery. Maintains proper levels of finished goods inventory. Provides visibility of system operation and measures of performance to management team. Performs audits to ensure smooth operations. Supports development and maintenance of Standard Operating Procedures and Work Instructions. Prepares and issues reports as required. Required participation in internal training as needed to perform the duties assigned to this role. Other duties as assigned Requirements: Minimum Qualifications (Knowledge, Skills and Abilities) U.S. Person status required do to export control 7+ years of related manufacturing experience Associates Degree in a related field preferred Strong attention to detail Capable of standing and or sitting for extended periods of time Ability to communicate effectively with coworkers and the management team. Must be well organized, flexible, and able to work in a fast-paced manufacturing environment Must thrive in a team-oriented and deadline-driven environment Ability to verbally communicate, read and comprehend written and verbal instructions in English Familiarity and skill with interpreting technical drawings and blueprints Demonstrated proficiency in MS Office programs- Excel, Word, Outlook, Power Point and Adobe Acrobat Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made. While performing the duties of this job, the employee is regularly required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. Constant specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. The employee may occasionally lift and /or move up to 25 pounds. The employee sits for extended periods of time at a computer station or work desk and is exposed to typical office environment conditions and noise levels. Required to wear Personal Protective Equipment (PPE) when working on the manufacturing floor where the employee may be exposed to moving mechanical parts and is occasionally exposed to high, precarious places; fumes or airborne particles; outside weather conditions; extreme heat and risk of electrical shock. The noise level in the manufacturing floor is usually loud. Note: This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills aptitudes and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship. The Company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable. This position falls under the International Traffic in Arm Regulation (ITAR). This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b (a) (3)) due to access to export-controlled technology. Company will require proof of status prior to employment. Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.

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