Connect Life Science · 5 hours ago
Director Quality System
United States
Full-time
Remote
Lead/Staff, Director/Executive
$200K/yr - $230K/yr
5+ years expConnect Life Science is a global Class III medical device manufacturer seeking a Director of Quality Systems to lead and scale its Quality function across multiple sites. This hands-on, strategic leadership role involves owning Quality Systems and Post-Market Surveillance while partnering with various departments and ensuring compliance with regulations.
Staffing & Recruiting
Hiring Manager
David Clifton
Responsibilities
Own and continuously improve Quality Systems and Post-Market Surveillance across global operations
Ensure ongoing compliance with US and international regulations (FDA, EU MDR, MDSAP, etc.)
Lead, mentor, and scale high-performing Quality teams
Drive CAPA effectiveness, KPI transparency, and system maturity
Partner cross-functionally to support product development, manufacturing, and lifecycle management
Act as a senior Quality representative with regulatory agencies and Notified Bodies
Identify proactive system and process improvements that support both growth and compliance
Travel up to ~25% to manufacturing and partner sites
Qualification
Required
5+ years of progressive Quality leadership in Class III Medical Devices
Deep hands-on experience with QMS and Post-Market Surveillance
Strong regulatory interface experience (FDA, EU Competent Authorities, Notified Bodies, etc.)
Working knowledge of 21 CFR EU MDR, MDSAP, ISO 13485 and 14971
Ability to translate regulatory expectations into practical, scalable systems
Calm, credible, and patient-focused leadership style
Comfortable influencing senior stakeholders and collaborating cross-functionally
Builds strong teams, not just compliant processes
Data-driven decision maker with a continuous-improvement mindset
Change manager with quality culture, integrity and empathy ethos
Bachelor's degree in relevant subject
Preferred
Quality certifications desirable
Benefits
Annual bonus
Equity
Full medical, dental, and vision coverage
401(k) with company match
Generous PTO and flexible working
Company
Connect Life Science
We are a highly specialised Life Science recruitment consultancy, partnering exclusively with the best talent in the industry and ensuring businesses deliver on their projects, with the goal to improve patient lives everywhere.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase