Job Title
Quality Director - MR Product Safety & PMSJob Description
At Philips, we are reshaping our Magnetic Resonance (MR) Quality organization to proactively detect and resolve issues earlier in the product lifecycle, ultimately leading to preventing problems. As the Quality Director for MR Product Safety & PMS, you will play a pivotal role in ensuring our products meet the highest standards of safety, customer trust, and compliance.
Your role:
Lead the global Product Safety & PMS function, integrating risk management and post-market surveillance into a single, agile team.
Drive proactive quality strategies across the product lifecycle—from design to post-market—ensuring early detection and resolution of safety risks.
Ensure regulatory compliance with ISO 13485, ISO 14971, EU MDR, and FDA requirements.
Oversee risk management and post-market surveillance processes.
Collaborate and ensure smooth execution of complaints handling, CAPA, and field actions, ensuring timely and effective resolution in collaboration with cross-functional teams.
Act as the primary interface with regulatory authorities on product safety matters.
Build and lead a high-performing team, fostering a culture of ownership, continuous improvement, and patient-centricity.
Collaborate closely with R&D, QMS, and Business Segment Quality leaders to embed safety and risk thinking into product development.
Contribute to the strategic direction of the MR Quality organization, supporting the transformation toward a leaner, more business-aligned structure.
You're the right fit if:
A bachelor degree in Life Sciences, Biomedical Engineering, or a related technical field. Master’s degree in quality or management is a plus.
10+ years of experience in Quality, Regulatory, or Product Safety roles, with at least 5 years in the medical device industry and 7 yrs experience in people management with experience in managing experts.
Deep expertise in ISO 13485, ISO 14971, and global regulatory frameworks (EU MDR, FDA).
Proven ability to drive change, prioritize and delegate effectively, and influence stakeholders at all levels.
Proven leadership of cross-functional and international teams, with a track record of building capabilities and end-to-end problem resolution.
Strong experience in Post-Market Surveillance, Risk Management, or CAPA processes.
Excellent communication and stakeholder management skills, with the ability to influence at all levels.
A strategic mindset with the ability to balance compliance, business needs, and patient safety.
How we work together
We believe that we are better together than apart. For this office-based teams, it means working in-person at least 3 days per week.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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- Discover our rich and exciting history .
- Learn more about our purpose .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .
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