Senior Supplier Quality Engineer – Supplier Qualification & Validation

About the role

The Senior Supplier Quality Engineer will lead quality assurance activities for supplier qualification, validation and ongoing performance across contract manufacturing sites and component suppliers in the medical device industry.

Key responsibilities

• Lead supplier selection, qualification, onboarding and risk assessments, maintaining the Approved Supplier List.
• Plan and execute risk‑based supplier audits in line with GMP, ISO 13485, FDA 21 CFR Part 820 and EU MDR requirements.
• Develop and monitor measurement systems for supplier quality, reliability, delivery and process capability.
• Manage supplier quality agreements, performance metrics and drive continuous improvement initiatives.
• Provide technical support for validation activities (IQ, OQ, PQ, process and test method validation) and ensure compliance throughout product lifecycle.
• Investigate supplier nonconformances, lead CAPA activities and root‑cause investigations.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, Manufacturing, Quality or related field (or equivalent experience).
• 5–8 years of supplier quality experience in a regulated medical device environment, including at least 5 years in medical device manufacturing.
• Demonstrated experience with supplier qualification, validation, and component qualification.
• Strong knowledge of ISO 13485, GMP, EU MDR/MDD and FDA QMS regulations.
• Excellent communication, stakeholder management and analytical skills.

Required skills

• ISO 13485 Lead Auditor certification (preferred).
• GMP and risk‑based quality management principles.
• Process validation, statistical analysis and root‑cause investigation techniques.
• Proficiency with ERP, PLM and Quality Management Systems.
• Microsoft Office suite.
• Familiarity with APQP, PPAP, Design Transfer and Supplier Development.
• Experience with machining, injection molding, extrusion, sterilization and electromechanical assemblies.