Supplier Quality Engineer

Supplier Quality Engineer
Location: Moundsview, CA
Job Type: C2C | Hybrid
Pay Rate: $50/hr
Industry: Medical Devices / Manufacturing Quality
End Date: 01-Jan-2026

Job Description

We are seeking a Supplier Quality Engineer with strong experience in medical device supplier management, PPAP documentation, and process validation. The role involves qualifying suppliers, managing PPAP deliverables, supporting inspection and test method validation, and ensuring compliance with Medtronics regulatory and quality standards. The engineer will collaborate with cross-functional teams to establish product acceptance strategies and provide technical support throughout the supplier qualification lifecycle while resolving supplier-related quality issues.

Responsibilities

• Qualify suppliers in accordance with organizational and regulatory requirements.
• Maintain and manage the Approved Supplier List (ASL) per purchasing control procedures.
• Prepare and release PPAP deliverables such as Control Plans, PFMEA, MSA, and FAI.
• Support PPAP execution and ensure robust qualification using IQ, OQ, and PQ processes.
• Define Receiving Inspection requirements and validate test methods per internal procedures.
• Collaborate with cross-functional teams to develop product acceptance sampling strategies.
• Deploy supplier quality tools (PFMEA, MSA, control plans) for new and legacy products.
• Provide technical support during supplier qualification and process validation activities.
• Ensure high-quality material and part delivery to prevent defects.
• Work closely with suppliers to resolve SCAPA/NCR issues in compliance with company standards.

Required Qualifications

• Bachelors degree in Engineering or a related field.
• Minimum 4+ years of experience in supplier quality engineering within medical devices.
• Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans.
• Familiarity with FDA and ISO 13485 quality standards.
• ISO 13485 Certified talent strongly preferred.
• Excellent communication, analytical, and problem-solving skills.
• Ability to work independently and in cross-functional teams.