Senior Quality Engineer (62016)

Position Summary

We are seeking a highly experienced and collaborative Senior 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 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 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.

Minimum Qualifications

·                  Bachelor’s degree in engineering, life sciences, or related technical discipline.

·                  5 years of experience in quality engineering, product development, or manufacturing with the medical device industry.

·                  Demonstrated experience with leading risk management and design control activities.

·                  Solid understanding of statistical methods used in capability analysis, trend analysis, sampling plans, and data interpretation.

·                  Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

·                  Familiarity with Class I medical devices and U.S. market requirements

·                  Proven ability to mentor cross-functional teams and drive quality initiatives.

·                  Excellent communication, problem-solving, and organizational skills.

Preferred Qualifications

·                  Master’s degree or advanced certification (e.g., ASQ CQE, CQA).

·                  Experience with EU MDR technical documentation and regulatory submissions.