Director, Quality Management Systems & Compliance

Job Description

The Director, Quality Management Systems & Compliance will provide strategic leadership to Enterprise Quality Management System (QMS) initiatives, drive audit/inspection readiness, and ensure high standards of quality and compliance in line with industry’s best practices.

Responsibilities

• Collaborates with senior leadership to influence and align quality strategy with business objectives, ensuring that quality management processes support operational efficiency, risk management, and strategic growth.
• Acts as a key advisor on quality-related risks and opportunities, providing expert guidance to executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decision-making.
• Develops, harmonizes, consolidates, and deploys standardized QMS frameworks, ensuring alignment with regulatory requirements and business needs.
• Proactively identifies, prioritizes, and leads projects aimed at improving quality compliance across all operational areas (Sites, CLS, etc.).
• Establishes harmonized processes and risk assessments to pinpoint compliance gaps and standardize remediation projects.
• Assists in overseeing the internal and external audit planning and execution for all locations and functions, ensuring audit readiness and follow‑up on findings.
• Manages relationships with Notified Bodies (NB) and supports sites in regulatory discussions and changes.
• Ensures consistency, robustness, and standardization of MR content and reporting structures across sites.
• Drives continuous improvement initiatives to enhance the structure and efficiency of Integrated Supply Chain (ISC) QMSs.
• Provides functional leadership of the QMS & Compliance Team, including succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development as well as planning, staffing, budgeting, managing priorities, and proposing/implementing methodological changes for a function/region/business.
• Facilitates cross‑functional collaboration at a strategic level, working closely with other departments to address and resolve high‑impact quality issues and ensure alignment with organizational quality objectives.
• Develops and maintains quality metrics and reports to track QMS performance, providing regular updates to management on quality performance and improvement initiatives.

Qualifications

• Minimum of 10+ years’ experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, such as document control, internal audits, CAPA, and training programs, ensuring their effective implementation, compliance, and continuous improvement.
• Minimum of 5+ years’ experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
• Robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global medical device standards.
• Detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
• Extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies) including Front Room expertise.
• Extensive experience developing/maintaining quality metrics and reports to track QMS performance, providing regular updates to management on quality performance and improvement initiatives.
• Minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field – Master’s degree preferred (MBA, MS, or equivalent).
• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Additional Information

• May travel up to 25% (Domestic & International).

Equal Employment Opportunity Statement

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section503 of the Rehabilitation Act of1973, the Vietnam Veterans’ Readjustment Act of1974 and TitleI of the Americans with Disabilities Act of1990, applicants that require accommodation in the job application process may contact 888‑367‑7223, option5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.