Philips Head Quality Ultrasound 

United States, District of Columbia, Washington 

627653405

Head of Quality, Ultrasound

Your role:

• Execute a single aligned quality strategy that is forward-looking and supports business growth, quality and regulatory compliance, improved product quality and customer experience.
• Acts as a key influence and change agent on the Systems Business MT and effectively work with the cross-functional leadership team to improve quality and compliance outcomes.
• Act as the management representative for all key regulatory agencies for product safety and quality (e.g: US FDA, EU MDR, TGA, MHLW, NMPA, etc.). Develop and maintain an effective working relationship with US FDA and other international regulatory bodies.
• Proactively ensure all facilities and functions consistently operate in a state of compliance and inspection readiness; proactively ensure all products, software, services and systems requirements meet global quality and regulation requirements.
• Lead, collaborate and partner with Site Quality leaders, Business MT, Philips Central teams, Markets and functions on strategic initiatives and transformations.
• Establish the vision and strategy to execute quality systems such that the QMS is compliant, effective and efficient for Ultrasound business.
• Provide leadership to the quality team to drive common goals and objectives that improve customer experience, operational excellence & proactive regulatory compliance.
• Establish a strong core Quality team and drive common goals and objectives that result in improved customer experience, operational excellence & proactive regulatory compliance.
• As a people manager, you are responsible for attracting, developing, engaging and retaining your team members. Acts as a coach and co-own the career development plans of your team members.

You're the right fit if:

• Degree in Engineering or Science, a Master’s degree preferred
• 15+ years global medical device industry
• Strong leadership skills and the ability to function well within a matrix organization
• Leadership experience in various aspects of Quality, such as design quality, quality systems, post-market surveillance and internal/external audit representation
• Experience in establishing Quality strategy, oversight, Quality systems, etc. preferably at group/corporate level in a large multi-national company
• Relevant training, experience and certification (ASQ Quality Manager, Auditor, Six Sigma, etc.), Continuous Improvement methodologies and Quality tools such as Lean, Six Sigma, 5 Why’s, Fishbone, etc.
• Extensive experience in Quality system metrics through use of leading indicators to drive high-performing systems and teams.
• Strong program management skills with a consistent record of accomplishment of leading key compliance programs through direct and/or indirect line management.
• Experienced knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, and EUMDR.
• Familiar with business process management frameworks including best industry practices as it pertains to QMS
• A highly collaborative influencer who is an effective communicator and relation builder/ networker
• Proven ability to lead cross-functional, diverse teams with challenging goals
• Willing to travel up to 25%

How we work together

This is an office-based role.

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 improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about our commitment to .

The pay range for this position in Washington is $175,000 to $323,000

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.