Quality Manager

We’re supporting a growing medical device company as they expand their team and look to hire a hands-on Quality Manager assist in leading Quality for their products.

This is a key hire with strong visibility, offering the opportunity to scale the Quality function, drive FDA inspection readiness, and partner closely with leadership to support both product development and commercialization.

What You’ll Do

• Develop, maintain and improve the QMS (FDA 21 CFR Part 820, ISO 13485)
• Support with FDA inspections and ISO audits, including readiness and remediation (483 responses)
• Oversee CAPA, complaints, and quality systems with a focus on effective root cause analysis
• Support product development
• Drive risk management activities
• Partner with Regulatory, R\&D, and Manufacturing teams
• Act as SME for Quality related matters across the company, including development and education of colleagues.

What We’re Looking For

• 8\+ years in medical device quality
• Deep knowledge of FDA 21 CFR Part 820 and ISO 13485
• Proven experience supporting or leading FDA inspections and audits
• Ability to operate hands-on while influencing cross-functional stakeholders

Preferred Qualifications

• Prior experience in a startup or scaling medical device company
• ASQ certification (CMQ/OE, CQE)
• ISO 13485 Lead Auditor certification
• Experience with MDSAP and/or EU MDR
• Background in implantable or life-sustaining devices