Sr. Manufacturing Quality Engineer

Senior 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.

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