Head of Quality, Ultrasound

Job TitleHead of Quality, UltrasoundJob DescriptionHead of Quality, Ultrasound Lead and execute the Quality strategy and team for the Ultrasound Business. Your responsibility will be to guide and support the Business Management Team (MT) in maintaining and continuously improving 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: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 preferred15+ years global medical device industryStrong leadership skills and the ability to function well within a matrix organizationLeadership 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 companyRelevant 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 QMSA highly collaborative influencer who is an effective communicator and relation builder/ networkerProven ability to lead cross-functional, diverse teams with challenging goalsWilling to travel up to 25%How we work togetherWe believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.This is an office-based role.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.Learn more about our commitment to diversity and inclusion.Philips Transparency Details The pay range for this position in Washington is $175,000 to $323,000The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional InformationUS 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.This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.Job SummaryJob number: 537896Date posted : 2024-10-31Profession: Quality & RegulatoryEmployment type: Full time