Senior Quality Engineer

<strong>About the Company</strong><br><br>Zap Surgical Systems is a surgical robotics start-up located in San Carlos, CA. Leveraging its unique gyroscopic motion and self-shielded design, our product, the Zap-X, is disrupting the industry and opening new frontiers in modern radiosurgery. Zap's employees thrive in an environment where multiple fields of study come together to solve challenging and important problems. You will be joining a diverse, cross-functional team that is bringing to market the most advanced stereotactic radiotherapy technology.<br><br><strong>Major Duties and Responsibilities</strong><br><ul><li>Manage the Company's Customer Complaint Handling Process (end to end project management of complaints including working with technical investigators, safety team, operations, and engineering personnel as needed). Will also participate in product safety team meetings and risk management meetings as required.</li><li>Project manage the transition of the customer complaint process from paper-based to an electronic (cloud based) solution.</li><li>Manage U.S. FDA MDR reporting and follow up.</li><li>Manage Company's CAPA process, including working closely with CAPA owners to develop CAPA champions that represent each function.</li><li>Ensure CAPA and customer complaint process meets defined process and KPI's.</li><li>Work closely with product risk manager to ensure any risks related to a customer complaint and CAPA are fully understood.</li><li>Present customer complaint and CAPA date at Management Reviews through compilation of trend analysis for key quality metrics including recommendations for improvement.</li><li>Review engineering design changes to ensure customer complaints/CAPAs are adequately addressed.</li><li>Support OUS Vigilance adverse event investigation and reporting.</li><li>Support Operations for the review and approval of Labeling, First Article and Incoming Inspections, DHR, Equipment forms and RMA Reports, as needed.</li></ul><br><strong>Experience, Skills, Education</strong><br><ul><li>Bachelors degree in science, engineering, or related discipline and 3 years related experience in a medical device company, or a Masters degree in science or biomedical engineering with at least one year experience in the medical device industry.</li><li>Experience as a quality engineer in a medical device environment with working knowledge of ISO 13485:2016/FDA QSR quality systems as well as EU MDR 2017/745, CAPA systems, complaints, supplier quality and process verification/validation.</li><li>Thorough understanding of risk management principles as required by ISO 14971:2019.</li></ul>