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 best practices.

Your role:

• 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.
• Develop, harmonize, consolidate and deploy standardized QMS frameworks, ensuring alignment with regulatory requirements and business needs.
• Proactively identify, prioritize, and lead projects aimed at improving quality compliance across all operational areas (Sites, CLS, etc.).
• Establish harmonized processes and risk assessments to pinpoint compliance gaps and standardize remediation projects.
• Assist in overseeing the internal and external audit planning and execution for all locations and functions, ensuring audit readiness and follow-up on findings.
• Manage relationships with Notified Bodies (NB) and support sites in regulatory discussions and changes.
• Ensure consistency, robustness, and standardization of MR content and reporting structures across sites.
• Drive continuous improvement initiatives to enhance the structure and efficiency of Integrated Supply Chain (ISC) QMSs.
• Responsible for 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.

You're the right fit if:

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

How we work together:

We believe that we are better together than apart. For our

Office-based

teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an Office role

.

About Philips:

We are a health technology company.

Additional Information:

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