Overview
Quality Director for the Premium and Clinical Segment in MR, leading and directing all aspects of quality assurance across the segment. Drive strategic planning, compliance management, and business transformation to ensure adherence to standards, regulatory compliance, and continuous improvement.
Responsibilities
* Lead quality assurance strategy development, execution oversight, and capability building to ensure compliance and excellence.
* Contribute to strategic planning by refining mission, vision, and policies to align with organizational goals.
* Oversee product release processes, ensuring compliance with safety and environmental regulations.
* Drive business transformation aligned with company strategy, enabling rapid growth through quality-led initiatives.
* Establish and manage supply chain quality assurance practices at the delivery model level.
* Direct product recall procedures, ensuring swift resolution and regulatory compliance.
* Own supplier qualification, audits, and assessments, and support internal and external audit readiness.
* Lead cross-functional discussions to resolve quality compliance issues and support business needs.
* Act as a senior-level expert, shaping company objectives and contributing creatively to goal attainment.
* Drive comprehensive talent management, including succession planning, performance management, and career development.
* Executes business transformation aligned with company business strategy, complies with quality regulations and budget, possesses a comprehensive grasp of solution strategy, facilitating end-to-end transformation for rapid growth, inclusive of skills and business partnerships.
* Oversees quality assurance activities, including strategy design, execution oversight, independent assessment, and compliance by design initiatives, and building and developing the quality assurance capability.
Qualifications
* Bachelor’s degree in Engineering, Physics, or a related technical discipline.
* Over 12 years of experience in Quality, Regulatory Affairs, or Product Safety, with deep expertise in the medical device industry. Strong knowledge of ISO 13485, ISO 14971, and global regulatory frameworks including EU MDR and FDA.
* Demonstrated leadership in managing quality professionals, with a solid track record in people management.
* Extensive experience across the full spectrum of quality management, including CAPA, risk management, regulatory compliance, design quality, change control, and continuous improvement initiatives.
* Proven ability to lead teams and audits, develop strategic plans, communicate effectively across functions, and deliver impactful results with strong business insight.
How we work together
We believe that we are better together than apart. For this office-based team, it means working in-person at least 3 days per week.
About Philips
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. Learn more about our business. 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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