Staff / Senior Staff Advanced Manufacturing Engineer, MedTech
Knowles Precision Devices
Senior Manager, Supplier QA
Exactech
full-time
Posted on:
Origin: • 🇺🇸 United States • Florida
Visit company websiteJob Level
Senior
About the role
- 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
- Mentor and develop the Supplier Quality team, fostering collaboration, growth, and continuous improvement
Requirements
- Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
- 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)
- ISO 13485 Lead Auditor Certification or ability to complete certification within one 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
