Supplier Quality Engineer II

What you'll do

• Lead investigations and resolve supplier-related quality and compliance issues during inspection or manufacturing.
• Drive corrective and preventive action (CAPA) activities including root cause investigation and effectiveness verification.
• Execute component qualification strategies, including Production Part Approval Process (PPAP) and release readiness assessments.
• Evaluate and approve supplier change requests to ensure continued compliance with regulatory requirements.
• Develop and maintain supplier quality controls, acceptance strategies, and approved documentation for products.
• Assess supplier performance through quality metrics, audits, and operational reviews to drive continuous improvement.
• Support internal and external audits by preparing records, responses, and corrective action plans.

What we're looking for

• Candidates must have a Bachelor's degree in Engineering, Science, or a technical field and 2+ years of experience.
• An advanced degree in Engineering, Science, or a technical field is acceptable with no prior experience required.
• Candidates must possess unrestricted U.S. work authorization at the time of hire.
• Experience supporting quality systems, manufacturing, or engineering activities in a regulated industry is preferred.
• Knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 is preferred.
• Experience with Lean Six Sigma or DMAIC methodologies is preferred; Green Belt or Black Belt certification is preferred.
• Experience with statistical analysis techniques, including Statistical Process Control (SPC), is preferred.
• Medical device industry experience, including component qualification or validation, is preferred.