Director, Quality Systems

JOB DESCRIPTION

The Director, Quality Systems is responsible for leading and advancing the company’s Quality Systems strategy, governance, and operational effectiveness to ensure ongoing compliance with global regulatory requirements and industry standards. This role provides leadership and oversight for key quality system functions, including Health Hazard Evaluations (HHE) and nonconformance management. The position will support all quality systems processes, including computer software assurance (CSA), corrective and preventive actions (CAPA), change control, document control, training, quality metrics and trending, and quality system continuous improvement.

• Lead and oversee Quality Systems activities to ensure compliance with internal procedures, applicable regulatory requirements, and international quality standards.
• Provide strategic and operational leadership for core Quality Systems processes, including HHE, nonconformance management, metrics and trending, and management review support.
• Drive continuous improvement initiatives to strengthen effectiveness, scalability, and efficiency of the Quality Management System (QMS).
• Monitor quality system performance through data analysis, KPI development, trend reviews, and risk-based metrics to identify opportunities for improvement and proactive mitigation.
• Partner with Regulatory Affairs, Engineering, Manufacturing, Supply Chain, Clinical, and other cross-functional teams to ensure quality systems are effectively integrated into business and product lifecycle processes.
• Support internal audits, external audits, customer audits, and regulatory inspections, ensuring readiness, effective coordination, timely response, and sustainable corrective actions.
• Ensure quality systems align with applicable regulatory requirements, including FDA, ISO, MDSAP, and global medical device regulations.
• Evaluate and mitigate quality and compliance risks through strong governance, escalation, and risk-based decision-making.
• Develop, review, and approve policies, procedures, work instructions, and quality system documentation to support compliance and operational excellence.
• Ensure management is appropriately informed of quality system performance, emerging risks, and improvement opportunities.
• Drive consistency and harmonization of quality systems practices across sites, functions, and applicable business areas.
• Lead quality system-related projects, system enhancements, and process improvement initiatives to support growth, efficiency, and regulatory compliance.
• Collaborate with Information Systems and business stakeholders on validation, implementation, or improvement of systems impacting quality processes.
• Build, mentor, and develop a high-performing team of quality professionals, fostering accountability, engagement, and continuous development.
• Provide leadership support for quality-related escalations, issue resolution, and compliance-related decision‑making.
• Perform other duties and special projects as assigned.

• 10+ years of progressive experience in Quality Assurance, Quality Systems or Quality Compliance within a regulated medical device or life sciences environment.
• 5+ years of leadership experience managing direct reports, managers, or cross‑functional quality teams.
• Strong knowledge of Quality Management Systems (QMS) principles and regulated quality processes.
• Deep understanding of applicable regulatory and industry requirements, including but not limited to:
  • FDA 21 CFR Part 820 / Quality System Regulation
  • FDA 21 CFR Part 803 and 806
  • ISO 13485
  • EU MDR
  • MDSAP
  • Risk‑based quality methodologies
• Experience leading HHE and nonconformance processes.
• Strong experience in CAPA, change control, quality metrics, and process improvement initiatives.
• Demonstrated ability to analyze quality data, trends, and performance indicators to support risk‑based decision‑making and process improvements.
• Strong project leadership experience with cross‑functional initiatives and enterprise process improvements.
• Excellent verbal and written communication skills with the ability to influence and collaborate effectively across all levels of the organization.
• Stro…