MedTech Quality Director - MDSAP & ISO 13485 Leader

Atrium Staffing LLC; New York (NY); On-site; USD 152,000 - 173,000; Full time

Benefits offered by this job

Competitive base salary

Equity participation

Health, dental, and vision coverage

Job summary

Atrium Staffing LLC is partnering with a mission-driven medical device company to recruit a Quality Director who will establish, direct, and continually strengthen the organization's QMS, ensuring all products, processes, and suppliers meet FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements.

The role includes oversight of contract manufacturers, audits, CAPA, risk management per ISO 14971, and collaboration with R&D, Regulatory, and Operations.

Qualifications

• Minimum 8 years in medical device quality with leadership experience.
• Deep knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP.
• Proven track record with contract manufacturers and supplier quality programs.

Responsibilities

• Lead and advance an ISO 13485–compliant QMS and drive CAPA systems.
• Oversee contract manufacturers, supplier qualification, audits, and documentation.
• Ensure regulatory readiness for FDA inspections and third-party audits.
• Direct risk management activities per ISO 14971 and design controls per 21 CFR 820.30.
• Collaborate with R&D, Regulatory, and Operations to embed quality in development.

Skills

Quality leadership

ISO 13485

FDA 21 CFR Part 820

MDSAP

Contract manufacturers oversight

Auditing

Risk management ISO 14971

Design controls 21 CFR 820.30

Regulatory affairs collaboration

Executive communication

Education

Bachelor's degree in Engineering, Life Sciences, or related

MBA or MS preferred

Job description

Atrium Staffing LLC is partnering with a mission-driven medical device company to recruit a Quality Director who will establish, direct, and continually strengthen the organization's QMS, ensuring all products, processes, and suppliers meet FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements.

The role includes oversight of contract manufacturers, audits, CAPA, risk management per ISO 14971, and collaboration with R&D, Regulatory, and Operations.