Supplier Quality Manager

Responsibilities

• Lead supplier selection, approval, evaluation, monitoring, and development activities
• Oversee supplier validation and qualification of processes, methods, and equipment
• Maintain and improve the Quality System as it relates to Supplier Quality Management
• Ensure the Approved Supplier List and supplier documentation remain accurate and compliant
• Ensure timely completion of supplier audits, assessments, business reviews, regulatory reviews, and quality agreements
• Serve as SME during internal and external audits related to supplier quality
• Manage and develop the Supplier Quality Engineering team, ensuring strong support for Operations and R&D projects
• Foster strong cross-functional collaboration with Manufacturing, Engineering, Quality Control, and Regulatory Affairs
• Travel domestically and internationally to suppliers as needed (25 - 30%)

• Bachelor’s degree in Engineering or Life Sciences
• 12+ years of Supplier Quality Engineering
• 5 or more years within Medical Device Industry
• 5 or more years of leadership experience managing teams in regulated environments
• Strong knowledge of FDA, ISO, MDR, QSMR, and IVDD regulations
• Experience conducting external supplier audits (Certified Lead Auditor preferred)
• Strong analytical, statistical, and problem-solving skills
• Solid understanding of Supplier Management, Design Controls, Process Validation, and manufacturing quality practices
• Excellent communication and leadership skills