Sr. Manufacturing Quality Engineer

Senior Manufacturing Quality EngineerOur 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 EngineeringApproximately 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.