Director of Quality
Director of Quality (MedTech)
Location: Minneapolis, MN (Hybrid)
Focus: Cardiovascular Devices (Class II & III)
We're partnering with a venture-backed med tech company in the Twin Cities as they move from development into clinical and early commercialization of innovative cardiovascular technologies.
They need a Director of Quality who can do more than maintain systems-you'll own and scale them.
What You'll Do
- Lead and evolve the QMS (ISO 13485 / FDA QSR)
- Drive design controls, risk, and V&V alongside Engineering
- Own inspection readiness and FDA-facing activities
- Build supplier quality and manufacturing controls for scale
- Act as a key partner to leadership on product and business decisions
Why It's Compelling
- True ownership in a scaling environment
- Executive-level visibility and influence
- Hands-on, build-focused role (not maintenance)
- Exposure to complex cardio devices (hardware + software)
What They're Looking For
- 12+ years in medical device quality (Class II/III)
- Strong background in design controls, risk, and QMS buildout
- Experience with FDA inspections and scaling organizations
- Comfortable in a fast-paced, startup environment
If you believe you'd make a good fit for this role, please apply in now.
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