Director of Quality and Compliance

About the role

The Director of Quality & Compliance plays a senior leadership role within Philips’ Image Guided Therapy Devices quality organization, focusing on quality system harmonisation, implementation of quality processes and tools, FDA/Notified Body compliance, and effective Management Review reporting.

Key responsibilities

• Lead, manage and develop the Image Guided Therapy Devices quality systems team, fostering an inclusive environment and strong employee engagement.
• Ensure the Quality Management System (QMS) operates and evolves in line with regulatory requirements, industry standards and internal policies, covering PDLM, manufacturing processes, change management, audits, CAPA, KPIs and objectives.
• Advise senior leadership on quality matters, shaping and executing the strategic vision for QMS programs aligned with business goals.
• Drive simplification and harmonisation of quality systems across sites, establish robust Management Review processes and reporting, and introduce necessary quality tools.
• Represent quality on the Business Category Leadership Team, partnering cross‑functionally to resolve challenges, drive operational excellence and embed quality objectives in key decisions.

Required profile

• Minimum 10+ years of experience in global FDA‑regulated medical device environments with functional and strategic leadership of diverse quality teams.
• Proven expertise in global medical device regulations and standards such as FDA, ISO 13485, ISO 14971 and EU MDR.
• Strong collaborative and strategic leadership skills with a track record in change management and stakeholder communication.
• Bachelor’s degree in Quality, Life Sciences, Engineering or a related field (required); Master’s degree in business, management or quality (strongly preferred).

Required skills

• FDA regulatory compliance
• ISO 13485
• ISO 14971
• EU MDR
• Quality Management System (QMS) implementation
• CAPA process management
• Change Management
• Internal and external audit execution
• KPI monitoring and reporting

What we offer

• Competitive base salary range of $170,000–$270,000 (US) depending on location.
• Comprehensive benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan, education reimbursement and more.