{"schemaVersion":"jobsearcher.job.v1","id":"74f591d779fbc9f7845934f6","url":"https://jobsearcher.com/jobs/74f591d779fbc9f7845934f6","canonicalUrl":"https://jobsearcher.com/jobs/74f591d779fbc9f7845934f6","title":"Senior Quality Engineer","description":"Position: Senior Quality Engineer\nLocation: Devens, MA\nEssential Job Duties and Responsibilities:\n· Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.\n· Analyze FAIRs, process and test method validation data before sending to the customer.\n· Lead customer complaint and CAPA investigations as required.\n· Manage ECOs, deviations, and documentation updates as required.\n· Generate and maintain applicable quality system documentation as needed.\n· Manages activities for handling healthcare products from receiving to shipping.\n· Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.\n· Participate in customer audits and provide input to any observations.\n· Train personnel as required\n· Review and discuss daily rejects and implement action plans\n· Make appropriate changes to prevent recurrence of quality related issues.\n· Make appropriate changes to fixtures or inspection methods and tools as required.\n· Regular attendance and professionalism.\nEssential Qualifications:\n· Bachelor of Science Degree\n· 10+ years of experience as a Quality Engineering in the healthcare industry\n· Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation\n· Must be able to read and understand 2D detailed part/article drawings\n· Must understand the use all quality related inspection equipment\n· Must have excellent problem solving and mistake proofing skills\n· Must have computer skills and familiarity with Word and Excel programs\n· Must have knowledge of SPC\n· Effective interpersonal and problem-solving skills\n· Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization\n· Excellent written, verbal, and presentation skills\nJob Type: Full-time\nPay: $100,000.00 - $110,000.00 per year\nBenefits:\n401(k)\n401(k) matching\nDental insurance\nHealth insurance\nLife insurance\nPaid time off\nVision insurance\nPeople with a criminal record are encouraged to apply\nEducation:\nBachelor's (Required)\nExperience:\nmedical device / Healthcare: 10 years (Required)\nQuality assurance: 10 years (Required)\nISO 13485: 5 years (Required)\n21 CFR Part 820: 6 years (Required)\nAbility to Relocate:\nDevenscrest, MA: Relocate before starting work (Required)\nWork Location: On the road","company":"Comtech Systems","rawCompany":"comtech systems","city":"Ayer","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-11T14:33:00.399Z","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":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Quality Engineer","description":"Position: Senior Quality Engineer\nLocation: Devens, MA\nEssential Job Duties and Responsibilities:\n· Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.\n· Analyze FAIRs, process and test method validation data before sending to the customer.\n· Lead customer complaint and CAPA investigations as required.\n· Manage ECOs, deviations, and documentation updates as required.\n· Generate and maintain applicable quality system documentation as needed.\n· Manages activities for handling healthcare products from receiving to shipping.\n· Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.\n· Participate in customer audits and provide input to any observations.\n· Train personnel as required\n· Review and discuss daily rejects and implement action plans\n· Make appropriate changes to prevent recurrence of quality related issues.\n· Make appropriate changes to fixtures or inspection methods and tools as required.\n· Regular attendance and professionalism.\nEssential Qualifications:\n· Bachelor of Science Degree\n· 10+ years of experience as a Quality Engineering in the healthcare industry\n· Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation\n· Must be able to read and understand 2D detailed part/article drawings\n· Must understand the use all quality related inspection equipment\n· Must have excellent problem solving and mistake proofing skills\n· Must have computer skills and familiarity with Word and Excel programs\n· Must have knowledge of SPC\n· Effective interpersonal and problem-solving skills\n· Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization\n· Excellent written, verbal, and presentation skills\nJob Type: Full-time\nPay: $100,000.00 - $110,000.00 per year\nBenefits:\n401(k)\n401(k) matching\nDental insurance\nHealth insurance\nLife insurance\nPaid time off\nVision insurance\nPeople with a criminal record are encouraged to apply\nEducation:\nBachelor's (Required)\nExperience:\nmedical device / Healthcare: 10 years (Required)\nQuality assurance: 10 years (Required)\nISO 13485: 5 years (Required)\n21 CFR Part 820: 6 years (Required)\nAbility to Relocate:\nDevenscrest, MA: Relocate before starting work (Required)\nWork Location: On the road","datePosted":"2026-08-11T14:33:00.399Z","dateModified":"2026-08-11T14:33:00.399Z","hiringOrganization":{"@type":"Organization","name":"Comtech Systems","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Ayer","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"74f591d779fbc9f7845934f6"},"url":"https://jobsearcher.com/jobs/74f591d779fbc9f7845934f6"}}