Quality Engineer – Medical Devices & Robotics Systems

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

Benefits offered by this job

Competitive salary and equity package

Flexible healthcare benefits with an I

Monthly health and wellness stipend

Visa sponsorship available for eligibl

Job summary

Andromeda Surgical, Inc. is seeking a Quality Engineer to help build and ship more units safely and efficiently.

You will work with engineering and manufacturing on the quality work behind the build—calibration, verification, supplier quality, and evidence for regulatory submissions. The role spans hardware and software quality within a small, collaborative team; you’ll report to the Quality and Regulatory Lead and help shape the evolving quality system as we scale manufacturing of autonomous

Qualifications

• 2 to 3 years in quality or regulatory in medical devices or a comparably regulated environment.
• 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. Ensure parts, equipment, and records are ready and correct before assembly; resolve quality issues during builds.
• Own supplier and incoming quality, from supplier qualification through incoming inspection and criteria.
• Own the equipment and calibration program end to end: scheduling, records, and calibration vendors.
• Write and run verification protocols; specify fixtures; support design control and changes: inputs, outputs, traceability.
• Automate manual checks, records, and handoffs to speed up builds; identify and replace slow steps.

Skills

Quality engineering

Medical devices

Documentation

Regulatory knowledge

Education

Bachelor's degree in Engineering

Tools

GD&T

Inspection equipment

Job description

Andromeda Surgical, Inc. is seeking a Quality Engineer to help build and ship more units safely and efficiently.

You will work with engineering and manufacturing on the quality work behind the build—calibration, verification, supplier quality, and evidence for regulatory submissions. The role spans hardware and software quality within a small, collaborative team; you’ll report to the Quality and Regulatory Lead and help shape the evolving quality system as we scale manufacturing of autonomous