Capstan Medical, Inc.
Product Quality Engineer - Robot
Santa Cruz, California
Sponsorship not specifiedDetected 6 days ago
Process ImprovementRoboticsGMPFDA RegulatoryMedical DevicesCommunicationCollaborationProblem Solving
About the role
- The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line, supporting testing activities, and supporting packaging validation and finished goods release for robotic devices.
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.
- Support creation of risk management files, including the development of Process FMEA
- Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes.
- Develop validation protocols, execute validation activities, and compile validation reports to ensure process robustness and consistency.
- 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.
- Implement Lean and Six Sigma principles to drive continuous improvement initiatives.
Requirements
- Experience with nonconforming material investigations and implementing effective CAPAs.
- Ability to work in a fast-paced environment
- Experience supporting development and manufacturing of surgical robotic devices.
- Strong understanding of GMP regulations and quality management systems.
- Excellent problem-solving skills and ability to apply root cause analysis methodologies.
Nice to have
- Master's degree is a plus.
- Bachelor's degree in Engineering or a related technical field.
Benefits
- We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
- We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
- Establish, implement, and support processes for field service and rework of robotic medical devices.
- Maintain Device History Records for robotic medical devices
Equal opportunity
- We are an equal opportunity employer.
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