Our mid-sized 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 is the role for you.

Your role with the company:

• 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.

Desired Profile:

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

• Approximately 7 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.

• Ability to thrive in a fast-paced, small company environment and be a hands-on contributor on the production floor.

• Excellent communication skills and the ability to handle direct feedback.