Senior Quality Engineer

About the role

We are partnering with a well-funded, clinical-stage medical device company advancing a breakthrough Class III technology through a pivotal IDE program and toward commercialization. This is an opportunity to join a growing team where quality is viewed as a strategic partner and plays a critical role in product development, manufacturing readiness, and regulatory success.

The Senior Quality Engineer will serve as a key cross-functional partner to R&D, Operations, Clinical, and Regulatory teams, owning quality activities across design controls, risk management, verification and validation, design transfer, supplier quality, and CAPA investigations. This is a highly visible role with the opportunity to make a significant impact on both the product and the organization as it scales.

Qualifications

• 6+ years of medical device quality engineering experience
• Strong knowledge of design controls, DHF/DMR documentation, and ISO 14971 risk management
• Experience leading V&V activities, requirements traceability, and validation efforts
• Working knowledge of ISO 13485 and FDA Quality System Regulations
• Experience with CAPA, NCR/NCMR, change control, supplier quality, and manufacturing readiness
• Prior Class III, IDE/PMA, implantable device, or startup experience is highly desirable

Benefits

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.