Manager, Supplier Quality
Position Summary:
The Supplier Quality Manager is responsible for developing, implementing, and maintaining supplier quality assurance processes to ensure compliance with regulatory requirements and company standards. This role plays a critical part in ensuring that all materials and components sourced from external suppliers meet stringent medical device quality standards, including FDA, ISO 13485, and other applicable regulations.
Key Responsibilities:
- Develop and manage the supplier quality program, including supplier qualification, audits, performance monitoring, and continuous improvement initiatives.
- Lead supplier assessments and audits to ensure compliance with regulatory and company requirements.
- Collaborate with Procurement, Engineering, and Manufacturing teams to resolve supplier-related quality issues.
- Establish and maintain supplier scorecards and KPIs to monitor performance and drive improvements.
- Manage non-conformance investigations, CAPAs, and SCARs related to supplier materials.
- Ensure supplier documentation (e.g., quality agreements, certifications, inspection records) is complete and up to date.
- Support new product development by ensuring supplier quality requirements are met during design transfer and validation phases.
- Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards.
- Lead risk management activities related to supplier quality, including FMEA and risk assessments.
- Train internal teams and suppliers on quality expectations and regulatory requirements.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
- 5+ years of experience in supplier quality management within the medical device industry.
- Strong knowledge of FDA regulations, ISO 13485, and GMP requirements.
- Experience with supplier audits, CAPA, SCAR, and root cause analysis tools (e.g., 5 Whys, Fishbone, etc.).
- Certification in Six Sigma, ASQ CQE, or similar is a plus.
- Excellent communication, negotiation, and project management skills.
- Proficiency in quality systems and tools (e.g., ERP, QMS, TrackWise, etc.).
Preferred Skills:
- Experience with IQ/OQ/PQ validation processes.
- Familiarity with risk-based supplier management approaches.
- Ability to travel domestically and internationally for supplier audits and inspections.
FAQs
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