Quality Assurance Engineer

Play a key role in ensuring patient safety and surgical excellence in this impactful Quality Assurance position. As QA Engineer, you’ll help ensure regulatory compliance for innovative surgical oncology solutions that are making a real difference in patients’ lives. Your work will directly support products used in critical cancer surgeries.

Why You Should Apply

Join a mission-driven team dedicated to transforming surgical oncology

Work on products that have a direct impact on patient safety and outcomes

Gain broad exposure across complaints, CAPAs, supplier quality, and product development

Be part of a collaborative, cross-functional environment where your voice matters

Less than 5% travel—mostly onsite work for strong collaboration

What You’ll Be Doing

Process and investigate product complaints related to patient safety

Prepare timely regulatory reports (e.g., MDRs) and maintain compliance documentation

Review and approve Device History Records and ensure supplier compliance

Participate in CAPA investigations and risk assessment processes (e.g., FMEAs)

Support design transfer and process validation activities during product development

Lead or contribute to quality system improvements and internal training

About You

Be able to do the job as described

Must have working knowledge of ISO 13485 and 21 CFR Part 820

Bachelor’s degree in an engineering discipline required

Certified Quality Engineer (CQE) preferred

Familiarity with technical files and complaint trend analysis strongly valued