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 ApplyJoin a mission-driven team dedicated to transforming surgical oncologyWork on products that have a direct impact on patient safety and outcomesGain broad exposure across complaints, CAPAs, supplier quality, and product developmentBe part of a collaborative, cross-functional environment where your voice mattersLess than 5% travel"”mostly onsite work for strong collaborationWhat You'll Be DoingProcess and investigate product complaints related to patient safetyPrepare timely regulatory reports (e.g., MDRs) and maintain compliance documentationReview and approve Device History Records and ensure supplier complianceParticipate in CAPA investigations and risk assessment processes (e.g., FMEAs)Support design transfer and process validation activities during product developmentLead or contribute to quality system improvements and internal trainingAbout YouBe able to do the job as describedMust have working knowledge of ISO 13485 and 21 CFR Part 820Bachelor's degree in an engineering discipline requiredCertified Quality Engineer (CQE) preferredFamiliarity with technical files and complaint trend analysis strongly valued

Created: 2025-05-31