Quality Manager, Medical Device CNC Machining (ISO 13485 / AS9100), Own the QMS and Report to the CEO

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• You report directly to the CEO. No corporate quality layer between you and the decision-maker.

• The QMS (quality management system) is yours: a team of 2 quality engineers and 6 inspectors, and the authority to shape the system as the company scales.

• You inherit a clean baseline: the most recent FDA and ISO 13485 audits closed with zero findings.

• There are real problems to own on day one, including live CAPAs (corrective and preventive actions) with a major customer that need a closer, not a caretaker.

• 30%+ growth every year for 8 straight years, with a plan to double by 2028. The building is bought and the power is upgraded.

• $120,000 to $150,000 base plus performance bonus.

• A hands-on quality leader who runs the system from the production floor, not from a desk.

• Someone who has personally led ISO 13485 or AS9100 audits multiple times, not sat in on one.

• A QM who can sit across from an OEM (original equipment manufacturer) customer quality team in a non-conformance dispute and hold their ground with inspection data.

• An early-to-mid-career builder who wants a seat to grow in for years, not a last stop before retirement.

• This is not the role for a metrics-and-meetings quality manager, anyone with a "not in my job description" reflex, or anyone expecting hybrid or remote.

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• Own the day-to-day quality management system in an ISO 13485 environment

• Lead internal, customer, and registrar audits end to end

• Run CAPA cycles through closure, including direct resolution with customer quality teams

• Lead IQ/OQ/PQ (installation, operational, and performance qualification) across a heavy pipeline of new part numbers and equipment

• Partner with production on first article inspection, in-process controls, and final release

• Coach and develop the 2 quality engineers and 6 inspectors on your team

• Cover a genuinely varied floor: Swiss lathes, 3-, 4-, and 5-axis mills, and wire and sinker EDM (electrical discharge machining)

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Required:

• ISO 13485 or AS9100 quality system experience (either one qualifies)

• Has personally led audits, internal and customer-facing

• IQ/OQ/PQ experience on equipment, processes, or both

• Quality management in a CNC machine shop or precision machining environment (you don't need to be a machinist, but you need to understand the floor)

• 5+ years managing a quality team

Nice to have:

• Class II/III medical device experience

• PPAP (production part approval process)

• CMM (coordinate measuring machine) programming: Verisurf, Calypso, PC-DMIS, or PolyWorks

• Bilingual English and Spanish

No degree required. Experience runs this role.

• On-site, full-time, direct hire

• Day shift with some overlap into second shift

• $120,000 to $150,000 base plus performance bonus

• Local candidates only; relocation is not offered, and we are unable to provide visa sponsorship

If this reads like your seat, apply and we'll move fast.