Summary from listing
The Quality Assurance Manager oversees production quality staff and quality systems across receiving inspection, cleanroom, final packaging, and product release areas. The role manages nonconforming events, product failures, corrective and preventive actions, quality instructions, test methods, engineering changes, audits, and compliance with medical device regulations including ISO 13485, 21 CFR Part 820, MDSAP, MDD, and MDR. It requires a bachelor’s degree or equivalent experience in engineering, quality engineering, or sciences, plus at least eight years of related experience in a regulated quality assurance or manufacturing or engineering environment.
