The Role
Support product quality for structural heart implant, delivery, and robotic devices. Lead sterilization and packaging validations, finished goods release, cleanroom production oversight, NCR/CAPA investigations, MRB participation, audits, documentation, and regulatory compliance (FDA QSR, ISO 13485). Collaborate with R&D, Regulatory, Manufacturing, and Engineering to resolve quality issues and drive process improvements.
Summary Generated by Built In
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.
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.
- Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.
- 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.
Requirements:
- Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.
- Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.
- Experience working in a cleanroom manufacturing environment.
- Experience with nonconforming material investigations and implementing effective CAPAs.
Skills Required
- Bachelor's degree in Engineering or related technical field
- Master's degree
- Knowledge of FDA regulations and ISO 13485
- Experience working in a cleanroom manufacturing environment
- Experience with nonconforming material investigations and implementing CAPAs
- Strong understanding of quality management systems
- Root cause analysis and problem-solving skills
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The Company
What We Do
Capstan Medical is a developer of robotic-enabled, minimally invasive solutions for treating structural heart disease. By merging surgical robotics with catheter-based technology and next-generation implants, the company aims to provide a patient-optimized approach to repair and replace heart valves, offering a significantly less invasive alternative to traditional open-heart surgery to improve patient outcomes and reduce recovery times.
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