Robotics Quality Engineer – MedTech Devices

Capstan Medical; Santa Cruz (CA); Vor Ort; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Health, dental, vision coverage

Flex time off

Team outings / recreational activities

Zusammenfassung

Capstan Medical, based in Santa Cruz, CA, seeks a Product Quality Engineer to support the manufacturing line for robotic medical devices. You will oversee quality during production, ensure GMP/ISO compliance, and drive CAPAs and NCR investigations with cross-functional teams.

This role requires a bachelor’s in engineering, 5+ years in medical device QA manufacturing, and hands-on experience with FDA regulations and ISO 13485.

Qualifikationen

• Bachelor’s degree in Engineering or related field required.
• Minimum 5 years in manufacturing quality engineering in medical devices.
• Deep knowledge of FDA regulations, ISO 13485, IEC 60601‑1.
• Experience with nonconforming material investigations and CAPAs.
• Ability to work in a fast-paced environment.

Aufgaben

• Oversee product quality during all production stages and field service.
• Ensure GMP/quality systems compliance throughout manufacturing.
• Lead NCR investigations, root-cause analysis, and CAPAs.
• Conduct MRB reviews and material decisions.
• Support field service, rework, and device history records.
• Develop validation protocols and perform IQ/OQ/PQ activities.
• Collaborate cross-functionally to resolve quality issues.
• Perform audits and apply Lean and Six Sigma for improvement.
• Prepare documentation for regulatory compliance and audits.

Kenntnisse

Quality engineering

FDA regulations

CAPA investigations

Lean Six Sigma

Document control

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering

Master's degree preferred

Jobbeschreibung

Capstan Medical, based in Santa Cruz, CA, seeks a Product Quality Engineer to support the manufacturing line for robotic medical devices. You will oversee quality during production, ensure GMP/ISO compliance, and drive CAPAs and NCR investigations with cross-functional teams.

This role requires a bachelor’s in engineering, 5+ years in medical device QA manufacturing, and hands-on experience with FDA regulations and ISO 13485.