Vp Of Quality (Medtech)

TL;DR

VP of Quality (Medtech): Leading the company's ISO 13485 certification and building the Quality Management System (QMS), integrating with engineering tools and workflows. Focus on ensuring compliance with medical device regulations, driving alignment between quality and engineering, and building a high-performing quality team.

Location: Remote, US or Canada - NYC preferred

Salary: $260,000-$300,000 + equity + benefits (including medical, dental, and vision)

Company

hirify.global offers the most complete and connected ecosystem in senior living, providing data-driven insights for informed clinical and operational decisions.

What you will do

• Own the company's ISO 13485 certification roadmap, from gap assessment to audit.
• Design and build the QMS, integrating with existing engineering tools and workflows.
• Establish and maintain core QMS processes, including document control, CAPA, and internal audit.
• Define quality plans, inspection criteria, and V&V strategies for electromechanical and software-embedded products.
• Lead root cause analysis and corrective action on hardware quality escapes.
• Build, mentor, and develop a lean, high-performing quality team.

Requirements

• 10+ years of quality experience in medical devices, with increasing leadership responsibility.
• Multiple ISO 13485 certifications personally led or co-led.
• Hands-on experience building a QMS from scratch within a PLM environment.
• Working knowledge of 21 CFR Part 820, ISO 14971, and IEC 62304.
• Experience spanning hardware/systems quality, software quality, and supply chain quality.
• Strong communicator and collaborator who can operate effectively with engineers, executives, and auditors alike.

Nice to have

• Prior experience as a Management Representative or Quality System owner at a growth-stage company.
• ASQ CQE, CQM/OE, or CQA certification.
• Background supporting FDA inspections for 510(k) or De Novo product types.
• Experience mentoring early-career quality professionals and building quality team culture from the ground up.

Culture & Benefits

• Equity + benefits (including medical, dental, and vision).
• Flexible PTO.