Director of Quality and Compliance

This role is office-based, requiring full-time presence in the company’s facilities at least 3 days per week.

About the role

The Director of Quality & Compliance plays an important leadership role within Philips’ Image Guided Therapy Devices quality organization, focused on Quality system harmonization and simplification, introduction and implementation of quality processes and tools, FDA and Notified Body compliance, and effective Management Review processes and reporting.

You will lead, manage, and develop the Image Guided Therapy Devices (IGTD) quality systems team, driving an inclusive, supportive environment and strong employee engagement. You will ensure the effective operation and evolution of the Quality Management System (QMS), maintaining compliance with applicable regulatory requirements, industry standards, and internal policies. This includes oversight of PDLM and manufacturing processes, change management, internal and external audit processes, CAPA processes, and management of Quality system KPIs and objectives.

As an advisor to senior leadership on all quality-related matters, you will formulate and implement the Business’ strategic vision for QMS programs aligned with business objectives, ensuring quality systems support organizational goals. You will enforce simplification and harmonization of quality systems across business sites and the sector, establish an effective Management Review process, and introduce quality processes and tools to ensure product quality and customer satisfaction.

You will act as the quality representative on the Business Category Leadership Team, providing strategic quality leadership and partnering cross-functionally to shape and execute category strategy, proactively resolve business and quality challenges, drive operational excellence, and ensure quality objectives are integrated into key business decisions.

Responsibilities

• Lead, manage, and develop the IGTD quality systems team, fostering an inclusive and supportive environment.
• Ensure the effective operation and evolution of the Quality Management System (QMS) in compliance with regulatory requirements, industry standards, and internal policies.
• Oversee PDLM and manufacturing processes, change management, internal and external audit processes, CAPA processes, and Quality system KPIs.
• Act as an advisor to senior leadership on quality-related matters and implement the strategic vision for QMS programs aligned with business objectives.
• Enforce simplification and harmonization of quality systems across business sites and the sector.
• Establish an effective Management Review process and routine reporting.
• Introduce and implement quality processes and tools to ensure product quality and customer satisfaction.
• Serve as the quality representative on the Business Category Leadership Team, providing strategic leadership and cross-functional partnership.
• Drive operational excellence and integrate quality objectives into key business decisions.

Requirements

• Minimum of 10+ years of experience in global, FDA-regulated medical device environments.
• Proven functional and strategic leadership of diverse quality teams in various aspects of Quality, including QMS implementation, simplification, standardization, CAPA, Change Management, and internal/external audit for multi-site businesses in a large, multinational, global/matrix organization.
• Experience utilizing and monitoring KPIs to assess team and QMS performance, driving high performance and process improvement.
• Proficiency in business process management frameworks and industry best practices related to FDA-regulated QMS.
• Expertise and knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO 13485, ISO 14971, and EU MDR for all classifications of medical devices.
• Bachelor’s degree in Quality, Life Sciences, Engineering, or a similar technical discipline (required). Master’s degree in business, management, or quality (strongly preferred).

Skills

• Highly collaborative and strategic leader with strong influencing skills.
• Proven experience in change management.
• Ability to effectively communicate and build relationships with internal and external stakeholders at all levels of the organization.

About Philips

Philips is a health technology company built around the belief that every human matters. Our mission is to improve access to quality healthcare for everyone, everywhere. Learn more about our business, history, purpose, and culture.

Pay

The pay range for this position is:

• Colorado Springs, CO: $162,000 to $258,000
• Plymouth, MN: $170,000 to $270,000
• San Diego, CA: $181,000 to $288,000

At Philips, the actual base pay offered may vary within the posted ranges depending on job-related knowledge, skills, experience, business needs, geographical location, and internal equity. Additional compensation may include an annual incentive bonus, sales commission, or long-term incentives.

Benefits

Employees are eligible to participate in Philips’ comprehensive Total Rewards benefits program, which includes:

• Generous PTO
• 401k with up to 7% company match
• HSA with company contribution
• Stock purchase plan
• Education reimbursement
• Additional benefits (details available here)

Additional Information

• US work authorization is required; the company will not sponsor work-authorized visas now or in the future.
• Company relocation benefits are not provided for this position.
• Candidates must reside in or within commuting distance of Colorado Springs, CO; Plymouth, MN; or San Diego, CA.
• This role may require up to 10% travel.