Supplier Quality Engineer

Supplier Quality Engineer is responsible for ensuring suppliers deliver quality materials, components, and services in compliance with regulatory and organizational requirements within the medical device industry.

Roles & Responsibilities:

• Ensure suppliers consistently deliver quality parts, materials, and services meeting Healthcare requirements.
• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Perform product and feature-level quality impact assessments and maintain necessary documentation.
• Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
• Conduct supplier risk segmentation and maintain risk profiles.
• Facilitate Supplier Quality Agreements and conduct supplier audits.
• Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
• Route documentation in PLM systems and follow up for approvals and release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.

Education & Experience:

• Bachelor's degree in engineering, Technical, or Scientific discipline.
• Minimum 5 to 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
• Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
• Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA)
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to work collaboratively with cross-functional and global teams.
• Proficiency in PLM systems and quality documentation tools.