- Senior
- Ufficio in Gainesville
The Senior Manager, Supplier QA leads supplier quality initiatives in alignment with ISO 13485 and 21 CFR Part 820, ensuring the compliance and performance of externally sourced materials, components, and services. This role collaborates with internal stakeholders to support supplier selection, qualification, auditing, and ongoing monitoring, while serving as a key liaison to drive supplier quality improvements. The Senior Manager provides technical guidance on supplier assessments, change notifications, and corrective actions, and oversees the implementation of quality-related programs and projects. A central focus of the role is mentoring and developing the Supplier Quality team, fostering a culture of collaboration, growth, and continuous improvement.
Key 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.
Skills Knowledge and Expertise
Education:
- Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
Experience:
- 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)
Functional/Technical Knowledge, Skills and Abilities Required:
- 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
