MedTech Robotics Quality Engineer - GMP/ISO Compliance

Capstan Medical Inc.; Santa Cruz (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Capstan Medical, based in Santa Cruz, CA, is seeking 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.

Qualifications

• Bachelor's degree in engineering required.
• 5+ years of medical device QA manufacturing experience required.
• Hands-on experience with FDA regulations and ISO 13485 required.

Responsibilities

• Oversee quality during production and support manufacturing line.
• Ensure GMP/ISO compliance across the production process.
• Lead CAPA and NCR investigations with cross-functional teams.

Skills

Quality Engineering

Medical devices

GMP/ISO compliance

CAPA management

NCR investigations

Education

Bachelor's degree in engineering

Job description

Capstan Medical, based in Santa Cruz, CA, is seeking 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.