Head of Quality, Magnetic Resonance Imaging

Head of Quality, Magnetic Resonance Imaging page is loaded Head of Quality, Magnetic Resonance Imaging Apply locations Best time type Full time posted on Posted 30+ Days Ago job requisition id 521737 Job TitleHead of Quality, Magnetic Resonance ImagingJob DescriptionHead of Quality, Magnetic Resonance ImagingLead 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 experienceStrong 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 representationExperience 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 SkillsHighly collaborative influencer who is an effective communicator and relation builder/ networkerProven ability to lead cross-functional, diverse teams with challenging goals.Willing to travel up to 25%About PhilipsWe 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 our business .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 .#LI-PH Similar Jobs (1) Material Planner - Magnetic Resonance locations Best time type Full time posted on Posted 2 Days Ago At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people's health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.We're committed to building a diverse and inclusive workplace culture where people feel heard, valued and connected. Because we know the possibilities are unlimited when people feel empowered to grow and succeed together.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members , marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran

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