Director of Quality Assurance
Listed on 2026-07-26
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Currently supporting a growing, founder-led Medical Device company seeking a Director Quality Assurance! The business operates across multiple US sites and supports the development and manufacturing of high-quality Class II/lll medical devices within a fast-paced environment. With a strong portfolio of products and increasing customer demand, this is a key leadership hire responsible for strengthening quality systems, driving compliance excellence, and leading audits!
This individual will take ownership of the overall Quality function, leading both strategic and hands-on operational quality activities across multiple manufacturing sites. The role will play a critical part in strengthening their QMS and act as the key point of leadership for FDA, customer and notified body interactions.
Key Responsibilities:- Lead the overall Quality and Regulatory function across multiple US manufacturing sites
- Own and drive QMS remediation, consolidation, and continuous improvement activities
- Act as primary lead for FDA inspections, notified body audits, and customer audits
- Oversee quality systems across design, manufacturing, and post-market surveillance
- Provide leadership and oversight of design quality engineering and QC functions
- Manage and develop a team of quality professionals (approx. 5 direct and indirect reports)
- Partner closely with engineering and operations to ensure quality is embedded across all processes
- Act as the key quality authority, balancing compliance requirements with operational delivery
- Support regulatory activities including device registrations, UDI, and FDA submissions as required
- Drive a culture of accountability, continuous improvement, and operational excellence
- 8+ years experience in Quality Assurane
- Strong background in Class II/lll medical devices and ISO 13485 / 21 CFR 820 environments
- Proven experience leading FDA inspections and external audits
- Demonstrated experience in QMS implementation, remediation, or consolidation
- Background in contract manufacturing or multi-site manufacturing environments strongly preferred
- Experience managing cross-functional teams within QA/QC and design quality environments
- Strong leadership capability with proven ability to develop and mentor teams
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