Quality Engineer

Andromeda Surgical•South San Francisco, CA

About The Position

Andromeda is building autonomous surgical robots to help surgeons perform procedures more safely, consistently, and efficiently. The Quality Engineer will work closely with engineering and manufacturing to establish, operate, and automate quality processes that support building and shipping units safely and efficiently. The role covers build readiness and quality issue resolution, equipment and calibration, supplier and incoming quality, verification, and design assurance evidence. Many processes are still being developed, so the engineer will build and run them while identifying manual steps that can be made faster and more reliable. Andromeda's quality system is established and certified to ISO 13485 and MDSAP. This is a generalist role spanning hardware and software quality work. The engineer will report to the Quality and Regulatory Lead and work directly with design engineering, manufacturing, and clinical teams. The scope is expected to grow as routine work is automated, with the opportunity to influence the role's future direction.

Requirements

2 to 3 years of experience in quality or regulatory work in medical devices or a comparably regulated environment.
Working knowledge of ISO 13485 and 21 CFR Part 820 / QMSR and their application to design control, supplier control, and equipment.
Experience with inspection, metrology, and calibration, including reading engineering drawings, selecting measurement methods, and managing calibration and equipment status.
Knowledge of design control and verification and validation methods, including protocol and report authorship, acceptance criteria, sample-size rationale, and traceability.
Ability to define and run a program at the same time.
Comfort working with incomplete information and shifting priorities, making decisions, and documenting the rationale.
Ability to identify and improve manual processes using practical tools such as spreadsheets, scripts, or forms.
Strong writing skills, particularly for written evidence that others must follow.
Ability to work closely with engineering, designers, and technicians.

Nice To Haves

Manufacturing or production support experience, including build records, first article inspection, and handling nonconformances during a live build.
Hardware experience, including mechanical inspection and GD&T, machining and finishing processes, and assessing supplier manufacturing capabilities.
Software experience, including software verification and validation, lifecycle records, and software quality within a device quality system.
Experience working across more than one area of a device program and quickly becoming effective in unfamiliar areas.
Internal auditor or ISO 13485 lead auditor training and experience conducting supplier audits.
Knowledge of statistical methods and sampling, including AQL and C=0 plans, reliability, and lifetime substantiation.
ASQ CQE.
IEC 62304 experience.
Experience with surgical robotics or other electromechanical devices combining motion control, sensing, and software.
Experience establishing quality programs from scratch.
Experience supporting notified body or FDA audits and inspections.

Responsibilities

Support day-to-day builds by ensuring required parts, equipment, and records are ready and correct, and by resolving quality issues during builds.
Own supplier and incoming quality, including supplier qualification, the approved supplier list, incoming inspection, and inspection criteria.
Manage the equipment and calibration program, including schedules, records, and calibration vendors.
Write and execute verification protocols, specify supporting fixtures, and support design control and design changes, including inputs and outputs, traceability, and verification requirements.
Identify and automate manual checks, records, and handoffs that slow builds or invite mistakes.

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