Capstan Medical, Inc.
Quality Engineer
Santa Cruz, California
Sponsorship not specifiedDetected 62 days ago
Process ImprovementFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- 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:
Responsibilities
- 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.
- 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.
- Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
- Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.
Requirements
- Experience working in a cleanroom manufacturing environment.
- Experience with nonconforming material investigations and implementing effective CAPAs.
Nice to have
- Bachelor's degree in Engineering or a related technical field.
- Master's degree is a plus.
Skills
- Strong understanding of quality management systems.
- Excellent problem-solving skills and ability to apply root cause analysis methodologies.
- Detail-oriented with effective organizational and documentation skills.
- Attention to detail, with a focus on accuracy and precision in quality-related activities.
- Ability to work independently in a fast-paced organization with competing priorities.
Benefits
- Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices.
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