Summary from listing
The Project Quality Engineer provides quality engineering support across the product lifecycle, including new product development, design changes, manufacturing transfers, and supplier changes. The role partners with R&D, AME, Supply Chain, and Manufacturing to ensure compliance with design controls, regulatory requirements, quality management systems, and safety standards. Responsibilities include approving design change requests and validation documentation, managing risk and CAPA activities, conducting root cause analysis, supporting audits, and training project teams. The position requires a bachelor's degree in a related field, at least three years of quality engineering experience in the medical device industry, and familiarity with ISO 13485 and FDA-regulated environments.
