{"schemaVersion":"jobsearcher.job.v1","id":"7f84af559dce1041b9620f83","url":"https://jobsearcher.com/jobs/7f84af559dce1041b9620f83","canonicalUrl":"https://jobsearcher.com/jobs/7f84af559dce1041b9620f83","title":"Quality Engineering Manager","description":"The Quality Engineering Manager will provide leadership to the Quality Engineering team and partner cross‑functionally with Engineering, Manufacturing, Operations, Regulatory Affairs, and Supply Chain to ensure products are designed, manufactured, and maintained in accordance with applicable regulatory requirements and quality standards. This role will oversee quality activities throughout the product lifecycle, including design controls, risk management, process validation, complaint handling, CAPA, audits, and continuous improvement initiatives. This individual will be responsible for ensuring compliance with FDA regulations, ISO 13485, MDSAP, EU MDR, and internal Quality Management System (QMS) requirements while fostering a culture of quality throughout the organization.\nRequired Qualifications Bachelor's Degree in Science, Engineering, or a related technical discipline from an accredited institution and managerial experience\nMinimum of 7 years of Quality Engineering, Quality Assurance, or Quality Systems experience within the medical device industry or combined aerospace and medical device experience\nDemonstrated knowledge of FDA Quality System Regulations, ISO 13485, MDSAP, and medical device quality system requirements\nExperience supporting product development and manufacturing activities, including design controls, risk management, verification and validation, and process validation\nWorking knowledge of inspection specification development, statistical analysis techniques, gage R&R studies, and GD&T applications\nExperience leading or participating in root cause investigations, CAPA activities, complaint investigations, and nonconformance management\nPrior experience supporting FDA inspections, notified body audits, and external quality audits\nExcellent verbal and written communication skills\nStrong leadership, organizational, and problem‑solving abilities\nAbility to effectively collaborate and influence cross‑functional teams across all levels of the organization\nPreferred Qualifications Master's Degree in Science, Engineering, or a related technical discipline\nImplantable medical device industry experience\nExperience leading Quality Engineering teams supporting both new product development and commercial manufacturing\nDemonstrated success driving continuous improvement initiatives and quality system enhancements\nASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent\n\n#J-18808-Ljbffr","company":"Interactive Resources","rawCompany":"interactive resources","city":"Gainesville","state":"FL","isRemote":false,"isActive":false,"createdAt":"2026-06-23T03:25:26.277Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"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":"Quality Engineering Manager","description":"The Quality Engineering Manager will provide leadership to the Quality Engineering team and partner cross‑functionally with Engineering, Manufacturing, Operations, Regulatory Affairs, and Supply Chain to ensure products are designed, manufactured, and maintained in accordance with applicable regulatory requirements and quality standards. This role will oversee quality activities throughout the product lifecycle, including design controls, risk management, process validation, complaint handling, CAPA, audits, and continuous improvement initiatives. This individual will be responsible for ensuring compliance with FDA regulations, ISO 13485, MDSAP, EU MDR, and internal Quality Management System (QMS) requirements while fostering a culture of quality throughout the organization.\nRequired Qualifications Bachelor's Degree in Science, Engineering, or a related technical discipline from an accredited institution and managerial experience\nMinimum of 7 years of Quality Engineering, Quality Assurance, or Quality Systems experience within the medical device industry or combined aerospace and medical device experience\nDemonstrated knowledge of FDA Quality System Regulations, ISO 13485, MDSAP, and medical device quality system requirements\nExperience supporting product development and manufacturing activities, including design controls, risk management, verification and validation, and process validation\nWorking knowledge of inspection specification development, statistical analysis techniques, gage R&R studies, and GD&T applications\nExperience leading or participating in root cause investigations, CAPA activities, complaint investigations, and nonconformance management\nPrior experience supporting FDA inspections, notified body audits, and external quality audits\nExcellent verbal and written communication skills\nStrong leadership, organizational, and problem‑solving abilities\nAbility to effectively collaborate and influence cross‑functional teams across all levels of the organization\nPreferred Qualifications Master's Degree in Science, Engineering, or a related technical discipline\nImplantable medical device industry experience\nExperience leading Quality Engineering teams supporting both new product development and commercial manufacturing\nDemonstrated success driving continuous improvement initiatives and quality system enhancements\nASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent\n\n#J-18808-Ljbffr","datePosted":"2026-06-23T03:25:26.277Z","dateModified":"2026-06-23T03:25:26.277Z","hiringOrganization":{"@type":"Organization","name":"Interactive Resources","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Gainesville","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7f84af559dce1041b9620f83"},"url":"https://jobsearcher.com/jobs/7f84af559dce1041b9620f83"}}