Quality Engineer - MedTech Robotics ISO13485

Andromeda Surgical, Inc.; South San Francisco (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Andromeda Surgical, Inc. is seeking a Quality Engineer to help us build and ship more units safely and efficiently. You’ll collaborate with engineering, manufacturing, and clinical teams to tighten quality in the hardware and software lifecycle, from calibration programs to design controls and verification.

You’ll automate where possible and grow the quality system as needs evolve. The role emphasizes hands-on quality work across devices, with a path to influence process improvements and

Qualifications

• 2 to 3 years in quality or regulatory in medical devices or a comparably regulated environment.
• Working knowledge of ISO 13485 and 21 CFR Part 820 / QMSR, and how they apply to design control, supplier control, and equipment.
• Inspection, metrology, and calibration: reading engineering drawings, choosing the right measurement method, and managing calibration and equipment status.
• Design control and V&V methods: protocol and report authorship, acceptance criteria, sample-size rationale, and traceability.

Responsibilities

• Support the build day to day. Make sure the parts, equipment, and records a unit needs are ready and correct before it goes together, and clear quality issues while the build is running.
• Own supplier and incoming quality, from qualifying suppliers and the approved supplier list through incoming inspection and the criteria we inspect against.
• Own the equipment and calibration program end to end: the schedule, the records, and the calibration vendors.
• Write and run verification protocols, specify the fixtures behind them, and support design control and design changes: inputs and outputs, traceability, and what verification a change requires.
• Automate the manual parts. Find the checks, records, and handoffs that slow a build down and make them faster and harder to get wrong.

Skills

Quality engineering

Medical devices

ISO 13485

Regulatory knowledge

Documentation/writing

Education

Bachelor's degree in Engineering

Tools

GD&T

Minitab

Job description

Andromeda Surgical, Inc. is seeking a Quality Engineer to help us build and ship more units safely and efficiently. You’ll collaborate with engineering, manufacturing, and clinical teams to tighten quality in the hardware and software lifecycle, from calibration programs to design controls and verification.

You’ll automate where possible and grow the quality system as needs evolve. The role emphasizes hands-on quality work across devices, with a path to influence process improvements and