Director of Quality Assurance

The Director of Quality Assurance is responsible for leading and overseeing NOVO’s Quality Management System (QMS) to ensure compliance with applicable global regulatory requirements and standards for medical devices. This role provides strategic and operational quality leadership across the organization, with an emphasis on product development. The Director partners with executive leadership and cross-functional teams to drive a strong culture of quality, regulatory compliance, and continuous improvement while enabling business growth and innovation.

• Lead, develop, and maintain NOVO’s Quality Management System in compliance with ISO 13485, FDA 21 CFR 820, and applicable global regulations.
• Provide strategic quality leadership and serve as the primary quality representative for executive management.
• Provide leadership, mentoring, and development of a company-wide quality approach to daily activities.
• Prepare and present QMS Management Reviews.
• Establish and monitor quality objectives, metrics, and KPIs to drive continuous improvement initiatives.
• Lead internal, external, supplier, and regulatory audits.
• Ensure effective corrective and preventive action (CAPA), complaint handling, and nonconformance processes.
• Ensure compliance with document/change control, training, and record-keeping requirements.
• Ensure hardware and software development processes comply with regulatory standards such as ISO 13485, FDA 21 CFR Part 820.30, and IEC 62304.
• Oversee design assurance and product development activities, ensuring compliance throughout the product lifecycle, which include:
• Lead and coordinate Medical Device File (MDF) documentation deliverables for both hardware and software components of medical device projects.
• Support the creation, review, and approval of development plans, requirements, design and phase end reviews, risk management file documentation (e.g., risk management plan, hazard analysis, FMEAs, risk reviews, risk report), outputs, verification protocols/reports, and design traceability.
• Create applicable requirement documents (e.g., system, hardware, software, etc.)
• Facilitate and participate in comprehensive risk management activities throughout the design process in accordance with ISO 14971, including software-specific risk analysis per IEC 62304.
• Ensure that risk mitigations are properly documented, tested, and verified.
• Support design verification activities, including test strategy development, verification test plans, protocols, and reports.
• Maintain traceability matrices ensuring linkage between product requirements, component requirements, design outputs, risk controls, and verification activities.
• Participate in design reviews and phase end reviews.
• Ensure compliance with project specific standards as applicable (e.g., IEC 60601 (electrical safety) and IEC 62366 (usability)).

• Expert knowledge of medical device regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, and applicable international requirements.
• Authority in design controls, risk management, verification, and supplier quality.
  
  Excellent strategic thinking, problem-solving, and decision-making abilities.
• Proven leadership, people management, and organizational development skills.
• Strong communication and influencing skills, including the ability to present to executive leadership and external regulators.
• Ability to balance compliance and business objectives in a fast-paced environment.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field preferred.
• 10+ years of experience in Quality Assurance within the medical device sector.
• 5+ years of leadership experience overseeing quality systems.
• Demonstrated experience leading and maintaining a compliant QMS in a regulated environment.

• Experience supporting Class II and/or Class III medical devices.
• Familiarity with global regulatory frameworks such as EU MDR, MDSAP, and other international markets.
• Background in software-driven devices, combination products, or implantable devices.
• Experience scaling quality systems in a growing or startup medical device company.