Description

You will own supplier quality processes and ensure material compliance throughout the product lifecycle.

Responsibilities

• Qualify suppliers and maintain the Approved Supplier List according to purchasing control procedures.
• Manage and release all PPAP deliverables, including Control Plans, MSA, PFMEA, and FAI.
• Support process qualification using IQ, OQ, and PQ methodologies with suppliers.
• Define Receiving Inspection requirements and validate test methods per internal procedures.
• Collaborate with suppliers to resolve SCAPA/NCR issues and implement product acceptance sampling strategies.

Required Skills

• Minimum 4+ years of experience in supplier quality engineering within the medical device industry.
• Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans.
• Familiarity with FDA and ISO 13485 standards.
• Experience managing supplier qualification and maintaining ASL.
• Ability to work independently and in cross-functional teams.
• Bachelor's degree in Engineering or a related field.

Key Skills

Education

Bachelor's degree