Exactech · 4 months ago
Senior Manager Supplier QA
Gainesville, FL
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expExactech is focused on optimizing the surgical experience and developing innovative orthopedic solutions. The Senior Manager, Supplier QA leads supplier quality initiatives to ensure compliance with medical device regulations while mentoring the Supplier Quality team and driving quality improvements.
BiotechnologyHealth CareManufacturingMedicalMedical Device
Responsibilities
Lead and manage the global process for supplier requirements, selection, qualification, approval, and ongoing monitoring in compliance with medical device regulations
Establish and maintain criteria for supplier audit schedules; lead audits (on-site, virtual, or documentation-based) to ensure supplier compliance
Review and approve Supplier Corrective Action Reports (SCARs), evaluating effectiveness and closure
Assess resource needs and allocate appropriately to meet internal and external customer requirements
Promote effective cross-functional collaboration with Development, Procurement Engineering, Purchasing, and other business units
Develop, implement, and track quarterly and annual quality goals and objectives aligned with organizational priorities
Ensure compliance with departmental safety policies and maintain a safe working environment
Participate in design transfer activities, providing supplier quality input during product development and launch
Lead or contribute to continuous improvement initiatives focused on enhancing supplier quality performance
Analyze supplier non-conformance trends, support investigations, and collaborate on corrective actions and inspection/test procedures
Partner with Purchasing and QA to monitor and improve supplier performance metrics
Support the development and negotiation of Quality Agreements and supplier Terms & Conditions
Lead justification and approval of supplier-driven change requests, including process and product deviations
Apply and uphold the Quality System and relevant domestic and international standards applicable to medical device manufacturing
Qualification
Required
Bachelor's Degree in a related field from an accredited institution required
10+ years of experience in Supplier Quality Management and the medical device industry or other regulated industry (Automotive, Aerospace)
Strong working knowledge of quality systems and risk management (ISO 13485, ISO 17025, ISO 14971, 21 CFR Part 820, Part 11, MDR)
Must have ISO 13485 Lead Auditor Certification or be able to complete this certification within a year
Demonstrated ability to understand technical drawings and Geometric Dimensioning and Tolerancing (GD&T)
Working knowledge of process and product validation (IQ, OQ, PQ)
Demonstrated understanding of Failure Mode and Effects Analysis (Design & Process)
Demonstrated understanding of Statistical Techniques, including Statistical Process Control (SPC) and experience implementing SPC or similar controls
Ability to work effectively in a team environment
Preferred
Master's Degree preferred
Company
Exactech
Exactech, Inc. is an orthopaedic company that develops, manufactures, markets, distributes and sells orthopaedic
0-1 employees
H1B Sponsorship
Exactech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (6)
2023 (8)
2022 (8)
2021 (11)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$85M2024-10-29Debt Financing· $85M
2017-10-23Acquired
1996-06-07IPO
Leadership Team
Richard Friedman
Chief Medical Officer
Recent News
2025-11-03
2025-09-19
Company data provided by crunchbase