QA Director & eQMS (Medical Devices)

Position Summary

The QA Director & eQMS is responsible for leading the Quality Assurance function and overseeing the implementation, maintenance, and optimization of the electronic Quality Management System (eQMS) for a Class III medical device organization. This role ensures compliance with global regulatory requirements while driving digital transformation of quality processes to support scalability, data integrity, and audit readiness.

The role serves as the QMS Management Representative and is accountable for ensuring adherence to FDA, ISO 13485, and EU MDR requirements.

Key Responsibilities

Quality System (QMS & eQMS) Leadership

• Own and maintain a compliant Quality Management System aligned with:
  • FDA 21 CFR Part 820 / QMSR
  • ISO 13485
  • EU MDR
• Lead selection, implementation, and optimization of the eQMS platform
• Ensure eQMS effectively supports:
  • CAPA, document control, training, complaints, audits
• Drive digital transformation of quality processes and continuous improvement

Regulatory & Inspection Readiness

• Ensure continuous inspection readiness (FDA, Notified Bodies)
• Lead regulatory inspections and third-party audits
• Oversee responses to FDA 483s, Warning Letters, and audit findings
• Ensure compliance with 21 CFR Part 11 (electronic records/signatures)

Design & Development Quality

• Ensure robust design control processes for Class III devices
• Oversee DHF, DMR, and technical documentation
• Partner with R&D on verification, validation, and design transfer

Manufacturing & Supplier Quality

• Lead quality oversight of manufacturing and supply chain
• Manage supplier qualification, audits, and performance
• Ensure compliance with validation programs (process, software, sterilization)

CAPA & Risk Management

• Own and drive the CAPA system and effectiveness
• Oversee complaint handling and MDR/Vigilance reporting
• Integrate risk management (ISO 14971) across the lifecycle

Leadership & Culture

• Build and develop a high-performing QA organization
• Promote a proactive quality culture across the company
• Collaborate cross-functionally with Regulatory, R&D, and Operations

Qualifications

Education

• Bachelor's degree in Engineering, Life Sciences, or related field required
• Advanced degree (MS/MBA) preferred

Experience

• 12-15+ years in medical device quality
• 5+ years in leadership roles
• Direct experience with Class III medical devices required
• Hands-on experience implementing or managing an eQMS strongly required
• Proven success leading FDA and global regulatory inspections
• Must currently work in Medical Devices

Technical Expertise

• Deep knowledge of:
  • FDA 21 CFR Part 820 / QMSR
  • ISO 13485
  • EU MDR
  • 21 CFR Part 11
  • ISO 14971 Risk Management
• Experience with eQMS platforms (EX. Veeva)

Compensation & Benefits

• Base Salary: $220,000 - $290,000
• Bonus: 25-35% performance-based
• Equity: Significant equity component
• Benefits: Medical, dental, vision, 401(k), PTO

Key Performance Indicators

• Successful regulatory inspections with minimal findings
• eQMS implementation success and adoption rates
• CAPA closure timelines and effectiveness
• Audit readiness and compliance performance
• Reduction in complaints and nonconformances