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.