Supplier Quality Engineer

Supplier Quality Engineer II (Onsite – 80%+) in Irvine, CA

Travel:
Up to 25% (domestic & international)

The Supplier Quality Engineer II will support design and development teams in qualifying critical materials and suppliers for innovative, life-saving medical devices. This role ensures supplier compliance with internal and regulatory requirements while collaborating cross-functionally with R&D, Operations, Quality, Sourcing, and Regulatory Affairs.

• Qualify and manage suppliers for OEM/custom materials and components
• Ensure compliance with FDA and global regulatory standards
• Support supplier audits, validation, and risk management activities
• Develop and validate inspection/test methods for incoming quality
• Drive root cause investigations (NCR, CAPA, SCAR) and corrective actions
• Support Design Development File and design control requirements
• Apply statistical and quality engineering tools (dFMEA, Gage R&R, RCA)

• Bachelor’s degree in Engineering or related Scientific field
• 2+ years of experience in Supplier Quality, Manufacturing, or Quality Engineering
• Experience in a highly regulated industry (Medical Device preferred)

• Experience with Class II or Class III medical devices
• Knowledge of FDA & international medical device regulations
• Strong problem-solving and statistical analysis skills
• Six Sigma/Lean or ASQ certification (CQE/CQA) preferred