Head of Quality, Magnetic Resonance Imaging - Best, Nederland - Philips

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Job Description

Head of Quality, Magnetic Resonance Imaging

Lead and execute the Quality strategy and team for the Systems business in Magnetic Resonance (MR) Business. Your responsibility will be to guide and support the Business Management Team (MT) of the fast-growing systems business to maintain and continuously improve product quality and compliance to exceed customer expectations. This involves being a confident and effective communicator on complex quality and regulatory compliance matters, global regulations and quality management related topics, and product knowledge.

Your role:

• Ensure the quality policy/system is planned, understood, implemented and maintained by ensuring compliance within the Business unit.
• Lead a team of quality professionals to execute a single aligned quality strategy that is forward looking and supports business growth, quality compliance, improved product quality and customer experience.
• Acts as a key influence and change agent on the cross-functional business unit leadership team to effectively 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/competent authorities.
• Proactively ensure all facilities and functions consistently operate in a state of compliance and inspection readiness; proactively ensure all software requirements meet global quality and regulatory requirements throughout the product lifecycle.
• Lead, collaborate and partner with site quality leaders, business (unit) management team(s), Philips Enterprise teams, markets and functions on strategic initiatives and transformations.
• Designs and implements a quality reporting system to identify Corrective and Preventive Actions to ensure product quality and compliance. Analyze product-related quality and performance data and apply statistical methods to proactively identify product quality issues and trends.
• Establish the vision and strategy to execute quality systems such that the QMS is compliant, effective and efficient for the MR business unit. Assure consistent and standardized execution of Philips Excellence Process Framework processes while identifying and implementing best practices and driving continuous process improvement.
• Provide leadership to the MR Quality team to drive common goals and objectives that improve customer experience, operational excellence & proactive regulatory compliance.
• Attract, develop, engage and retain quality talent to establish a strong and capable team. Acts as a coach and co-own the career development plans of your team members.
• Overall AOP / Fiscal responsibility.

You're the right fit if:

• Degree in Engineering or Science, a Master's degree would be a distinct advantage.
• 15+ years global medical device industry with significant class 2 industry experience
• 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, EUMDR.
• Familiar with business process management frameworks including best industry practices as it pertains to QMS.
• Experience in change management.
• Business Insight and strong Business Partnering Skills
• 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%

About Philips

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• Discover our rich and exciting history.
• Learn more about our purpose.
• Read more about our employee benefits.

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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