Senior Quality Engineer
About The Position
We are seeking a highly experienced and collaborative Senior Quality Engineer to join the Quality team. This role leads risk management activities, supports new product introductions (NPIs), and contributes to sustaining engineering for primarily Class I and II medical devices marketed in the United States. The role requires experience with ISO 13485, ISO 14971, design control, validations, and quality systems; experience with EU MDR technical documentation is preferred. The Senior Quality Engineer works cross-functionally with R&D, suppliers, and internal teams to build quality into product design and development, support product and supplier changes, and maintain compliance with applicable regulatory and quality system requirements. The role also supports audits and investigations and provides technical guidance to teams.
Requirements
- Bachelor’s degree in engineering, life sciences, or a related technical discipline.
- At least 5 years of experience in quality engineering, product development, or manufacturing within the medical device industry.
- Demonstrated experience 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.
Nice To Haves
- Master’s degree or advanced certification, such as ASQ CQE or CQA.
- Experience with EU MDR technical documentation and regulatory submissions.
Responsibilities
- Create, maintain, and continuously improve 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
