Client Overview:
Our client is a growing, mission-driven medical device organization focused on scaling efficiently while maintaining high quality and compliance standards. They foster a collaborative environment where team members help shape quality practices across the business. The company has approximately 15 - 20 employees and is looking to add a Quality Director to their team. Salary/Hourly Rate$152k - $173kPosition Overview The Quality Director is a senior leader accountable for establishing, directing, and continually strengthening the organization's Quality Management System (QMS). This leader ensures that products, processes, and suppliers satisfy applicable regulations, including FDA 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP). The role holds major responsibility for contract manufacturer oversight and acts as the primary quality point of contact for outside manufacturing partners, regulators, and auditors. The Quality Director (if not local to the NYC/NJ area) will need to travel to meet with the third-party manufacturer in New Jersey and to the New York City office for one week per month. Relocation assistance can also be provided for candidates interested in moving to the NYC/NJ area.
Responsibilities Of The Quality Director:- Manage and continually enhance an ISO 13485-compliant QMS.Maintain compliance with FDA 21 CFR Part 820, MDSAP, MDR, and other relevant regulations.
- Direct the internal audit program and Management Review process.
- Establish and track quality metrics, KPIs, and CAPA systems.
- Oversee document control, change control, and records management.
- Act as the primary quality contact for contract manufacturers and vendors.
- Create and run supplier qualification, auditing, and monitoring programs.
- Review and approve supplier quality agreements, approved vendor lists, and manufacturing documentation.
- Provide quality oversight for product transfers, new CM onboarding, and process validations.
- Investigate and resolve quality escapes, nonconformances, and supplier complaints tied to contract manufacturers.
- Perform routine onsite and remote contract manufacturer audits to confirm regulatory and QMS compliance.
- Lead the organization's MDSAP certification and ongoing surveillance audits.
- Prepare the company for MDSAP audits covering FDA, Health Canada, ANVISA, TGA, and PMDA requirements.
- Maintain audit readiness across all MDSAP member countries.
- Keep technical files, Design History Files (DHF), and Device Master Records (DMR) current to support global registrations.
- Work with R&D and Engineering to build quality into the full product development lifecycle, including design controls under 21 CFR 820.30.Lead risk management activities in accordance with ISO 14971.Oversee complaint handling, MDR/MDV reporting, and post-market surveillance.
- Analyze trends and drive continuous improvement efforts.
- Recruit, develop, and lead a high-performing Quality team.
- Promote accountability, quality, and continuous improvement company-wide.
- Partner with Operations, Engineering, Regulatory Affairs, and Commercial teams.
- Report on quality performance to executive leadership and the Board as needed.
- Required Experience/Skills For The Quality Director
- At least 8 years of quality experience within the medical device industry.
- At least 5 years in a quality leadership or management role.
- In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP.Demonstrated success managing contract manufacturers and supplier quality programs.
- Experience leading FDA inspections and/or third-party regulatory audits.
- Solid understanding of design controls, ISO 14971 risk management, and post-market surveillance.
- Strong written and verbal communication skills, including the ability to present to executives and regulators.
- Ability to be in the NYC/NJ area one week per month.
- Preferred Experience/Skills For The Quality DirectorASQ certification, such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE).MDSAP auditor training or ISO 13485 Lead Auditor certification.
- Experience with Class II and/or Class III medical devices.
- Experience in a startup or scale-up medical device environment.
Education Requirements:
Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline is required. Advanced degree (MBA or MS) in a relevant field is preferred.
Benefits:
Competitive base salary with performance-based bonus opportunities.
Comprehensive health, dental, and vision coverage.
Equity participation.
Opportunity for the Quality Director to shape the quality culture at a growing medical device company.
Collaborative, mission-driven workplace.
Client-provided benefits available, upon eligibility.
