{"schemaVersion":"jobsearcher.job.v1","id":"a6044c2ba322287b5bbe9332","url":"https://jobsearcher.com/jobs/a6044c2ba322287b5bbe9332","canonicalUrl":"https://jobsearcher.com/jobs/a6044c2ba322287b5bbe9332","title":"Manager, Quality Engineering","description":"Manager, Quality Engineering\r\nDepartment: Quality\r\nEmployment Type: Full Time\r\nLocation: Gainesville, FL\r\nReporting To: Director, Quality Management Systems\r\nDescription\r\nThe Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.\r\nKey Responsibilities\r\n\r\nQuality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS; maintain audit readiness and certification compliance.\r\nQuality Engineering Leadership: Lead and develop the Quality Engineering team; align goals, performance, and resources to business objectives.\r\nProduct Realization (Design & Manufacturing): Oversee design controls, risk management, verification/validation, and process validation; ensure compliance with GD&T, inspection, and statistical requirements.\r\nCAPA & Investigations: Drive root cause analysis, corrective/preventive actions, and cross-functional resolution of quality issues.\r\nComplaints & Nonconformance: Lead investigation, containment, disposition, and timely resolution of complaints and nonconforming product; escalate risks as needed.\r\nData & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality Governance.\r\nAudit Support: Serve as SME during internal and external audits/inspections.\r\n\r\nSkills Knowledge and Expertise\r\nEducation\r\n\r\nBachelor's Degree in Science from an accredited institution required; Master's Degree preferred\r\n\r\nExperience\r\n\r\nMinimum of 7 years experience, preferably in orthopedic or other medical device field.\r\nWorking understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.\r\nMinimum of 0-5 years prior QA Engineering management experience in a Medical Device Company.\r\nExperience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications\r\nPrior audit experience with FDA and notified bodies.\r\n\r\nFunctional/Technical Knowledge, Skills and Abilities Required:\r\n\r\nExcellent verbal, written communication and leadership skills.\r\nAbility to work with all organizational functions.","company":"Exactech","rawCompany":"exactech","city":"Gainesville","state":"FL","isRemote":false,"isActive":false,"createdAt":"2026-06-11T14:39:49.519Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, Quality Engineering","description":"Manager, Quality Engineering\r\nDepartment: Quality\r\nEmployment Type: Full Time\r\nLocation: Gainesville, FL\r\nReporting To: Director, Quality Management Systems\r\nDescription\r\nThe Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.\r\nKey Responsibilities\r\n\r\nQuality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS; maintain audit readiness and certification compliance.\r\nQuality Engineering Leadership: Lead and develop the Quality Engineering team; align goals, performance, and resources to business objectives.\r\nProduct Realization (Design & Manufacturing): Oversee design controls, risk management, verification/validation, and process validation; ensure compliance with GD&T, inspection, and statistical requirements.\r\nCAPA & Investigations: Drive root cause analysis, corrective/preventive actions, and cross-functional resolution of quality issues.\r\nComplaints & Nonconformance: Lead investigation, containment, disposition, and timely resolution of complaints and nonconforming product; escalate risks as needed.\r\nData & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality Governance.\r\nAudit Support: Serve as SME during internal and external audits/inspections.\r\n\r\nSkills Knowledge and Expertise\r\nEducation\r\n\r\nBachelor's Degree in Science from an accredited institution required; Master's Degree preferred\r\n\r\nExperience\r\n\r\nMinimum of 7 years experience, preferably in orthopedic or other medical device field.\r\nWorking understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.\r\nMinimum of 0-5 years prior QA Engineering management experience in a Medical Device Company.\r\nExperience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications\r\nPrior audit experience with FDA and notified bodies.\r\n\r\nFunctional/Technical Knowledge, Skills and Abilities Required:\r\n\r\nExcellent verbal, written communication and leadership skills.\r\nAbility to work with all organizational functions.","datePosted":"2026-06-11T14:39:49.519Z","dateModified":"2026-06-11T14:39:49.519Z","hiringOrganization":{"@type":"Organization","name":"Exactech","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Gainesville","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a6044c2ba322287b5bbe9332"},"url":"https://jobsearcher.com/jobs/a6044c2ba322287b5bbe9332"}}