Principal Quality Engineer

Position Summary

We are seeking a highly experienced and collaborative Principal Quality Engineer to join our Quality 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 deep expertise 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 post-market surveillance.
• Provide process and test method validation expertise to suppliers and internal teams.
• Ensure compliance with ISO 13485, FDA QSR, and internal quality system requirements.
• Support internal and external audits.
• Lead or support internal investigations, including CAPA and nonconformances.
• Mentor and provide technical guidance across teams.
• Foster a culture of quality, continuous improvement, and cross-functional collaboration.