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