Product Quality Engineer – MedTech Robotics (Onsite)

Capstan Medical Inc.; Santa Cruz (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

Capstan Medical Inc. is seeking a Product Quality Engineer to provide quality engineering support for our manufacturing line, support testing activities, and assist in packaging validation and finished goods release for robotic devices.

The role requires a Bachelor’s in Engineering and at least 5 years in medical device quality engineering, with strong knowledge of FDA, ISO 13485, and GMP. Based onsite in Santa Cruz, CA, you will work with cross-functional teams to ensure product safety and

Qualifications

• Bachelor's degree in Engineering or related technical field; master's preferred.
• Minimum 5 years' experience in manufacturing quality engineering within the medical device industry.
• Deep knowledge of FDA regulations, ISO 13485, IEC 60601-1, and related quality & safety standards for robotic medical devices.
• Experience with nonconforming material investigations and implementing effective CAPAs.
• Ability to work in a fast-paced environment.

Responsibilities

• Oversee product quality during all stages of production and field service.
• Ensure GMP compliance and quality management systems throughout manufacturing.
• Lead investigations into nonconforming materials and products with cross-functional teams to identify root causes and implement CAPAs.
• Conduct Material Review Boards and participate in materials decision making.
• Establish and support processes for field service and rework of robotic medical devices.
• Maintain Device History Records for robotic devices.
• Support development of risk management files, including Process FMEA.
• Lead process validation activities (IQ/OQ/PQ) for new and existing manufacturing processes.
• Develop validation protocols and compile validation reports for robustness and consistency.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive process improvements.
• Perform audits of manufacturing processes to ensure adherence to quality standards.
• Implement Lean and Six Sigma to drive continuous improvement.

Skills

Quality engineering

GMP knowledge

Cross-functional

Education

Bachelor's degree in Engineering

Tools

QMS

Job description

Capstan Medical Inc. is seeking a Product Quality Engineer to provide quality engineering support for our manufacturing line, support testing activities, and assist in packaging validation and finished goods release for robotic devices.

The role requires a Bachelor’s in Engineering and at least 5 years in medical device quality engineering, with strong knowledge of FDA, ISO 13485, and GMP. Based onsite in Santa Cruz, CA, you will work with cross-functional teams to ensure product safety and