Vice President of Quality

Vice President of Quality – Class III Neurostim Implant for OSA 🧠💤

Location: Remote (~5% travel)

Company Type: Stealth-stage medical device startup focused on implantable neuromodulation therapies

We’re partnered with a stealth-stage medtech startup developing a fully implantable hypoglossal nerve stimulator for obstructive sleep apnea (OSA), a CPAP (Continuous Positive Airway Pressure) alternative targeting patients with moderate to severe OSA who don’t tolerate existing treatments.

Key Responsibilities 🔍

Quality Systems & Compliance

• Take ownership of the existing QMS (21 CFR Part 820); assess, optimize, and scale it for pivotal and PMA phases
• Maintain and improve document control, DHF structure, change management, and traceability
• Lead CAPA, non-conformance, complaint handling, and supplier quality processes
• Act as the company’s primary contact for FDA inspections and audits
• Support IDE supplements, clinical documentation, and future PMA submission
• Prepare quality infrastructure to support commercial manufacturing

Cross-functional Collaboration

• Partner with R&D, Clinical, and Operations to embed quality throughout the development lifecycle
• Oversee cleanroom and assembly QA, inspection protocols, and device release
• Manage external partners: CMOs, test labs, and service providers
• Initially hands-on; expected to build and lead a small QA team over time

Candidate Profile 👤

• 8–15 years in Quality roles within regulated MedTech (Class III implantable experience required)
• Track record of scaling a 21 CFR Part 820-compliant QMS at early- to mid-stage companies
• Direct participation in FDA inspections, ideally pre-approval or PMA-stage
• Background in neurostimulation, cardiac rhythm management, or similar active implantables
• Familiar with ISO 13485, ISO 14971, IEC 60601, and risk management for Class III systems
• Not looking for a playbook — comfortable leading, fixing, and scaling existing systems
• Bonus: Experience with PMA submissions or IDE-based clinical trials

Why This Role Is Attractive 💡

• QMS already in place for IDE with the chance to refine, own, and scale it through commercialization
• Timing: join during pivotal prep and influence every key decision going into PMA
• Leadership: reports to CEO, with direct input across R&D, clinical, and regulatory
• Highly competitive salary: Attractive & competitive salary with a bonus attached
• Equity: 1–2%, depending on experience and fit
• Flat structure: fast decision cycles, no red tape
• Parallel growth: commercial leadership being hired in tandem to support market-facing strategy