# Quality Engineer - Company: [Capstan Medical]() - Location: Santa Cruz, California - Team: Quality - Employment type: Full-time - Posted: May 21, 2026 ## Job description The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line and supporting finished goods release for structural heart implant, delivery, and robotic devices. *Product and Operations Quality responsibilities include:* * Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices. * Provide guidance on sterilization processes and validations to ensure product safety and compliance. * Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers. * Oversee packaging validation activities to ensure product integrity and stability during storage and transportation. * Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements. * Oversee product quality during all stages of production in a cleanroom manufacturing environment. * Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence. * Participate in materials decision making as a member of Material Review Board * Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment. * Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards. *Documentation and Compliance responsibilities include:* * Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions. * Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards. * Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings. ## Apply [Apply on Capstan Medical]() Canonical job page: