Job Description
We are seeking a highly experienced and collaborative Senior Quality Engineer to join our client'sQuality team. This role will be instrumental in leading risk management activities, supporting new product introductions (NPIs), and sustaining engineering efforts for primarily Class I and II medical devices marketed in the US. The ideal candidate will bring experience in ISO 13485, ISO 14971, design control, validations, and quality systems, with a strong preference for experience in EU MDR technical documentation.

Key Responsibilities

· Own the creation, maintenance, and continuous improvement of Risk Management Files in accordance with ISO 14971.

· Facilitate cross-functional risk assessments throughout the product lifecycle.

· Partner with R&D to ensure quality is built into the design and development of new products.

· Provide quality engineering support for design changes, product updates, supplier diversification, and ...