Sr Quality Engineer - Exempt

The Senior Quality Engineer will support the site’s transition to a new PLM system, ensuring quality system requirements, design controls, and compliance expectations are appropriately integrated and maintained throughout the implementation. Day-to-day responsibilities include partnering with cross-functional teams (Quality, R&D, Manufacturing, Regulatory, IT), reviewing and approving PLM-related workflows and documentation, supporting validation and risk activities, and ensuring continuity of Quality operations during the transition. The role may also help offload routine Quality Engineering activities across the site to maintain operational stability.

• Quality Systems & Change Management: Strong experience with medical device quality systems, including change control, document control, nonconformance/CAPA processes, and quality record approval in compliance with ISO 13485 requireme...