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.