{"schemaVersion":"jobsearcher.job.v1","id":"0dadd1e64f1a5402317b1da6","url":"https://jobsearcher.com/jobs/0dadd1e64f1a5402317b1da6","canonicalUrl":"https://jobsearcher.com/jobs/0dadd1e64f1a5402317b1da6","title":"Senior Quality Engineer","description":"The Senior Quality Engineer serves as a key quality representative supporting manufacturing, engineering, operations, supply chain, and customer quality activities at the Rancho Dominguez manufacturing facility. This position is responsible for ensuring products are manufactured in compliance with applicable quality standards, regulatory requirements, and company procedures while driving continuous improvement initiatives that enhance product quality, reduce risk, and improve customer satisfaction.\n\nThe Senior Quality Engineer provides technical leadership for quality investigations, CAPA activities, risk assessments, process validation, change management, supplier quality activities, and customer complaint investigations. This role partners closely with cross-functional teams to maintain a robust Quality Management System (QMS) and support business growth while maintaining compliance with ISO 9001, GMP principles, and customer requirements.\n\nEssential Duties and Responsibilities:\n\nUse investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes.\nPerform FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability concerns.\nMonitor the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place.\nPrepares quality/inspection plans, procedures and instructions, and product / raw materials specifications.\nPerforms testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, or test methods.\nReviews manufacturing planning for appropriate quality requirements.\nPrepares appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures documentation contains the necessary criteria and provisions for effective inspection and testing.\nCompile and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the completion and effectiveness of corrective actions.\nPerform investigations and prepare reports for customer complaints.\nConducts or participates in ISO audits, internal audits, and Customer audits.\nPrepare and review Quality Technical Agreements and supplier evaluation surveys.\nSupport process/product improvement projects, product design reviews, products and raw materials non-conformance investigations, review and disposition.\nPerform ISO, GDP, and technical training.\nInterface at all organizational levels within the company, customers, and suppliers.\nAct as direct quality liaison with Engineering, Manufacturing, Marketing and customers.\nMay serve as Lab Safety Coordinator in conjunction with the company’s Hazard Communication Program.\n\nTravel Requirements:\n\nOccasional travel may be required based on business needs.\n\nEducation and/or Work Experience Requirements:\n\nBachelor’s degree in Engineering or Life Science.\n7+ years Quality Engineering and/or Manufacturing Engineering experience.\nDemonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations.\nKnowledge of Investigative / problem solving tools and scientific/technical investigations.\nExperience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data analysis.\nGood interpersonal, verbal communication and writing skills. Able to express thoughts and concepts at both technical and administrative level.\nDemonstrated ability to proficiently review technical and quality requirements, deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.).\nGood knowledge and skills in the use of advanced computer programs for word processing, spreadsheets, database and flow charts\n\nPreferred Qualifications:\n\nASQ Certified Quality Engineer (CQE)\nASQ Certified Quality Auditor (CQA)\nLead Auditor Certification\nExperience with MasterControl or comparable eQMS platforms\nExperience supporting filtration products, single-use technologies, medical devices, biologics, or pharmaceutical manufacturing\n\nPhysical Requirements:\n\nAbility to sit at a computer desk for an extended period of time\nAbility to work in a laboratory environment and exposure to hazardous materials\nRegularly required to stand, sit, walk, use hands and arms\nLift/ or move up to 25 pounds","company":"Repligen","rawCompany":"repligen","city":"Compton","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-09-10T09:42:31.866Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Quality Engineer","description":"The Senior Quality Engineer serves as a key quality representative supporting manufacturing, engineering, operations, supply chain, and customer quality activities at the Rancho Dominguez manufacturing facility. This position is responsible for ensuring products are manufactured in compliance with applicable quality standards, regulatory requirements, and company procedures while driving continuous improvement initiatives that enhance product quality, reduce risk, and improve customer satisfaction.\n\nThe Senior Quality Engineer provides technical leadership for quality investigations, CAPA activities, risk assessments, process validation, change management, supplier quality activities, and customer complaint investigations. This role partners closely with cross-functional teams to maintain a robust Quality Management System (QMS) and support business growth while maintaining compliance with ISO 9001, GMP principles, and customer requirements.\n\nEssential Duties and Responsibilities:\n\nUse investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes.\nPerform FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability concerns.\nMonitor the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place.\nPrepares quality/inspection plans, procedures and instructions, and product / raw materials specifications.\nPerforms testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, or test methods.\nReviews manufacturing planning for appropriate quality requirements.\nPrepares appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures documentation contains the necessary criteria and provisions for effective inspection and testing.\nCompile and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the completion and effectiveness of corrective actions.\nPerform investigations and prepare reports for customer complaints.\nConducts or participates in ISO audits, internal audits, and Customer audits.\nPrepare and review Quality Technical Agreements and supplier evaluation surveys.\nSupport process/product improvement projects, product design reviews, products and raw materials non-conformance investigations, review and disposition.\nPerform ISO, GDP, and technical training.\nInterface at all organizational levels within the company, customers, and suppliers.\nAct as direct quality liaison with Engineering, Manufacturing, Marketing and customers.\nMay serve as Lab Safety Coordinator in conjunction with the company’s Hazard Communication Program.\n\nTravel Requirements:\n\nOccasional travel may be required based on business needs.\n\nEducation and/or Work Experience Requirements:\n\nBachelor’s degree in Engineering or Life Science.\n7+ years Quality Engineering and/or Manufacturing Engineering experience.\nDemonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations.\nKnowledge of Investigative / problem solving tools and scientific/technical investigations.\nExperience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data analysis.\nGood interpersonal, verbal communication and writing skills. Able to express thoughts and concepts at both technical and administrative level.\nDemonstrated ability to proficiently review technical and quality requirements, deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.).\nGood knowledge and skills in the use of advanced computer programs for word processing, spreadsheets, database and flow charts\n\nPreferred Qualifications:\n\nASQ Certified Quality Engineer (CQE)\nASQ Certified Quality Auditor (CQA)\nLead Auditor Certification\nExperience with MasterControl or comparable eQMS platforms\nExperience supporting filtration products, single-use technologies, medical devices, biologics, or pharmaceutical manufacturing\n\nPhysical Requirements:\n\nAbility to sit at a computer desk for an extended period of time\nAbility to work in a laboratory environment and exposure to hazardous materials\nRegularly required to stand, sit, walk, use hands and arms\nLift/ or move up to 25 pounds","datePosted":"2026-09-10T09:42:31.866Z","dateModified":"2026-09-10T09:42:31.866Z","hiringOrganization":{"@type":"Organization","name":"Repligen","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Compton","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0dadd1e64f1a5402317b1da6"},"url":"https://jobsearcher.com/jobs/0dadd1e64f1a5402317b1da6"}}