{"schemaVersion":"jobsearcher.job.v1","id":"bc7b28fa4c985a680ce650e3","url":"https://jobsearcher.com/jobs/bc7b28fa4c985a680ce650e3","canonicalUrl":"https://jobsearcher.com/jobs/bc7b28fa4c985a680ce650e3","title":"Sr Quality Engineer","description":"Job Description\nIn this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.\n\nResponsibilities\n\nProvide Quality Engineering support for commercial medical device products.\n\nDevelop, modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product.\n\nCollaborate with engineering and manufacturing functions to ensure quality standards are in place.\n\nDevise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.\n\nDesign or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.\n\nMay specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.\n\nApply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.\n\nEnsure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.\n\nAble to present quality during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation\nPresent technical data to groups within and outside the organization.\n\nUtilize quality tools to include risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.\n\nRequirements\n\nMedical Device Design & Development.\n\nRisk Management: dFMEA, pFMEA, Statistical analysis.\n\nTechnical Writing: IQs, PQs, TMVs.\n\nHands on experience on upstream new product development vs downstream manufacturing transfer and operations quality.\n\nWorking knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016.\n\nDemonstrated working knowledge of process validation, statistical methods, risk management.\n\nGreen Belt Six Sigma/DRM Training/Certification is preferred, but not required.\n\nASQ-CQE, CQA, CBA or equivalent certifications preferred, but not required.\n\nSAP QM or SPC Software experience preferred, but not required.\n\nBachelor's Degree in Engineering, Science or technical field AND 5-7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Danvers","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-06-17T04:17:11.591Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"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"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr Quality Engineer","description":"Job Description\nIn this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.\n\nResponsibilities\n\nProvide Quality Engineering support for commercial medical device products.\n\nDevelop, modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product.\n\nCollaborate with engineering and manufacturing functions to ensure quality standards are in place.\n\nDevise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.\n\nDesign or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.\n\nMay specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.\n\nApply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.\n\nEnsure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.\n\nAble to present quality during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation\nPresent technical data to groups within and outside the organization.\n\nUtilize quality tools to include risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.\n\nRequirements\n\nMedical Device Design & Development.\n\nRisk Management: dFMEA, pFMEA, Statistical analysis.\n\nTechnical Writing: IQs, PQs, TMVs.\n\nHands on experience on upstream new product development vs downstream manufacturing transfer and operations quality.\n\nWorking knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016.\n\nDemonstrated working knowledge of process validation, statistical methods, risk management.\n\nGreen Belt Six Sigma/DRM Training/Certification is preferred, but not required.\n\nASQ-CQE, CQA, CBA or equivalent certifications preferred, but not required.\n\nSAP QM or SPC Software experience preferred, but not required.\n\nBachelor's Degree in Engineering, Science or technical field AND 5-7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:17:11.591Z","dateModified":"2026-06-17T04:17:11.591Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Danvers","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bc7b28fa4c985a680ce650e3"},"url":"https://jobsearcher.com/jobs/bc7b28fa4c985a680ce650e3"}}