Quality Engineer

Andromeda Surgical; 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

About Andromeda

Andromeda is building autonomous surgical robots designed to help surgeons perform procedures more safely, consistently, and efficiently. Our engineers work across robotics, software, hardware, machine learning, and clinical operations to bring robotic systems from concept to real-world clinical deployment. We are a small, highly collaborative team that values ownership, curiosity, technical rigor, and the ability to move quickly from idea to execution.

The Role

We are looking for a Quality Engineer to help us build and ship more units, faster and safely. You will work day to day with engineering and manufacturing on the quality work that gets units out the door: the equipment and calibration behind the build, incoming and supplier quality, and the verification and design assurance evidence each unit depends on. Most of these processes are still being built. You will build them, run them, and automate them as you go.

A lot of what we do today is manual. A big part of this job is finding the steps that slow a build down or invite mistakes and replacing them with something faster and harder to get wrong. Expect the scope to grow with you.

Our quality system is established and certified to ISO 13485 and MDSAP. This is a generalist role. The product is hardware and software together and the quality work crosses both, so range matters. Hardware experience helps: mechanical inspection, machining and finishing, judging what a supplier's process can hold. Software experience is beneficial as well: verification and validation, lifecycle records, how software quality fits into a device quality system.

You will report to the Quality and Regulatory Lead and work directly with design engineering, manufacturing, and clinical teams.

What You'll Do

• 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.

This list will grow. As you automate the routine parts, the job moves toward the harder problems, and you will have a say in where it goes next.

What We're Looking For

Quality engineering:

• 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.

Breadth (preferred):

• Manufacturing or production support: build records, first article inspection, and handling nonconformances on a live build.
• Hardware: mechanical inspection and GD&T, machining and finishing processes, and judging a supplier's manufacturing process.
• Software: software verification and validation, lifecycle records, and how software quality fits into a device quality system.
• Work across more than one area of a device program. We are looking for a generalist who can pick up an unfamiliar area and get useful quickly.

Ownership and judgment:

• Able to define a program and run it at the same time.
• Comfortable with incomplete information and shifting priorities. Willing to make a call and write down why.
• Looks for the manual step that could be simpler and fixes it. Spreadsheets, scripts, forms, whatever gets it done.
• Strong writing. Most of this job ends up as written evidence someone else has to follow.
• Works embedded with engineering. A lot of this job happens in conversation with designers and technicians.

Nice to have

• Internal auditor or ISO 13485 lead auditor training, and experience running supplier audits.
• Statistical methods and sampling: AQL and C=0 plans, reliability and lifetime substantiation.
• ASQ CQE.
• IEC 62304 experience (software lifecycle for medical devices).
• Surgical robotics, or other electromechanical devices combining motion control, sensing, and software.
• Experience standing up quality programs from scratch.
• Experience supporting notified body or FDA audits and inspections.

What Success Looks Like

A year in, we are building more units than we are today and quality is not the reason any of them are late. Incoming inspection catches problems before they reach a build. The equipment and calibration program runs without anyone asking about it. Several things that used to be manual are not anymore. Engineering brings you in early because you are useful to them.

Why Join Andromeda?

You will work with a small, highly technical team on hard problems in robotics, software, and healthcare. Quality engineering here is still being built, and you will have a lot of say in how it works. How fast we get a safe product in front of surgeons depends on this work.