Quality Manager, Medical Device CNC Machining; ISO/AS9100), Own QMS and Report to t
Listed on 2026-07-10
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Quality Assurance - QA/QC
Production QC/QA, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Overview
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.
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.
Key Responsibilities- 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).
- 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.
- 5+ years managing a quality team.
- CMM (coordinate measuring machine) programming:
Verisurf, Calypso, PC‑DMIS, or Poly Works. - Bilingual English and Spanish.
No degree required. Experience runs this role.
Day shift with some overlap into second shift.
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.
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