Sr. Manufacturing Quality Engineer

Our small medical device client is adding a Senior Manufacturing Quality Engineer to join their growing team. This is a critical role focused on leading our validation and verification efforts as they pursue ISO 13485, EU MDR, and CE Mark certifications. If you are a hands‑on quality professional with a strong background in medical device manufacturing and a desire to make a significant impact, this role is for you.

• Lead and execute validation activities for the entire manufacturing process.

• Perform 100% verification for approximately 30% of their manufacturing processes that do not require validation.

• Collaborate with cross‑functional teams to ensure timely completion of validation master plans and individual validation activities.

• Contribute to the continuous improvement of our manufacturing processes, focusing on increasing capacity and efficiency.

• Support other quality initiatives such as CAPAs, non‑conformances, root cause analysis, and auditing as needed.

• BS Engineering, prefer Manufacturing, Mechanical, or Industrial Engineering

• Approximately 5 years of experience in manufacturing quality within the medical device industry.

• Proven expertise in validation and verification processes.

• Experience with ISO 13485, EU MDR, and CE Mark certifications.

• Strong understanding of quality tools, including CAPAs, non‑conformances, root cause analysis, and auditing
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• Ability to thrive in a fast‑paced, small company environment and be a hands‑on contributor on the production floor.