supplier quality engineer

Position Summary:

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.

Key Responsibilities:

• Ensure suppliers consistently deliver quality parts, materials, and services meeting Medtronic 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.

Qualifications & Experience:

• Bachelor’s degree in engineering, Technical, or Scientific discipline.

• Minimum 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).

Skills:

• 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.

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