Quality Assurance Engineer

Our client is seeking a QA Engineer to support day-to-day quality engineering activities in a fast-paced medical device manufacturing environment (clean room
8). This person will help work through a backlog of investigations while supporting manufacturing quality, risk review, and nonconformance activities. The role is heavily tied to the manufacturing side of the business and requires someone who understands how quality supports production in a regulated device setting. The consultant will spend the first couple of weeks learning internal systems, SOPs, and documentation practices before taking on more ownership with the Quality Engineering team.

• Provide quality engineering support for day-to-day manufacturing activities
• Review and support NCMRs, NCRs, and related investigations
• Assess quality issues such as OOT or OOS events and help confirm risk is controlled
• Partner with Quality Engineers on investigation follow-up and documentation review
• Learn internal SOPs, systems, and workflows, then take on more independent ownership
• Support a fast-paced, highly automated manufacturing environment with strong problem-solving and documentation skills

• 4+ years of quality engineering experience in medical device manufacturing
• Strong experience supporting manufacturing investigations and NCMR’s
• ISO 13485 and ISO 14971
• Class II or Class III medical device manufacturing
• Comfortable working in or around cleanroom manufacturing operations
• Strong problem-solving skills and ability to work in a fast-paced setting