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Posted: Friday, April 28, 2017 2:45 PM

Your challenge As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve. In this role working under the direction of the Vice President & Head of Quality & Regulatory, CT/AMI, you will be challenged to coordinate the ongoing activities of the Quality Management System Deployment (QMSD) program at the Cleveland, OH site of Philips, including program planning, execution, process and program effectiveness metrics, and implementation of tools to support the program. You will communicate on a regular basis to all levels of the organization including but not limited to Quality leadership, HR leadership, senior business unit leadership, and functional team leadership to achieve program outcomes. Role will also include direct involvement in daily tasks necessary for successful program execution including defining program timelines and milestones, driving execution of planned tasks, problem resolution across organizational boundaries, and communicating program monitoring information. Additionally, you will be responsible for the development and implementation of contracts/statements of work with external suppliers and corporate purchasing. You will recommend options to the Vice President and Head of Quality & Regulatory, CT/AMI for decisions and decision escalation when needed. You will have authority to modify program processes, as necessary, to achieve program goals. Responsibilities Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). Key areas of responsibilities (KARS) for this role include: • Responsible for program management, stakeholder management, and accessing subject matter expertise for the QMSO program • Monitoring progress against program phases • Managing day-to-day activities with the program team • Working with VP to identify appropriate resources needed • Developing schedules to ensure timely completion of the program • Coordinating the program budget • Identifying and communicating opportunities for required stakeholders that support the program • Developing scorecards for program implementation status • Consolidating and reporting metrics on program progress, implementation and effectiveness • Delivering management reporting for a variety of stakeholders and teams. (e.g., Quality, Operations) • Managing and facilitating tasks, meetings and action items related to governance activities. (e.g., core teams, extended teams, steering committees, implementation teams, councils) • Coordinating daily tasks necessary for successful program execution • Creating and maintain mechanisms to monitor program status, budget, and timetables using both readily available and specialized software applications • Collaborating with VP and other stakeholders to establish program objectives, timelines, milestones, and budgets • Coordinating with Quality training program in the identification of training opportunities related to the programs’ process, policies or tools • Collaborating with relevant stakeholders in the structure, delivery, management and analysis of metrics related to relevant processes • Analyzing process performance data to determine trends and make recommendations where improvements are needed • Coordinating the development, planning, and deployment of business process harmonization efforts chartered by relevant process sub-teams • Preparing and delivering presentations related to various aspects of assigned programs • Perform other duties as assigned Your team As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. Location Cleveland, Ohio We are looking for A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year. · Bachelor’s Degree · Project Management Certification (PMP) strongly desired · Minimum of 7 years of work experience · Experience in a role driving process improvement or culture change within an organization · Experience working within a regulated environment · Excellent verbal and written communication skills · Proficient with MS Project, MS Excel, MS Power PowerPoint, and MS Word · Strong project management skills · Ability to work effectively independently and within teams · Ability to demonstrate high energy, positive and professional image · Experience in positions responsible for interacting with and influencing senior-level executive leadership (including C-level) · Organizational savvy, ability to navigate in a large, global organization Preferred Qualifications: • Project leadership experience in a regulated or mature process-oriented industry (e.g., FDA, FAA, SEC, DoD) • Experience delivering presentations at various levels in an organization from front-line to C-level • Demonstrated experience influencing stakeholders at multiple levels in the organization • Advanced Degree a plus • More than 7 years of work experience • Ideal experience will include the medical device industry in quality or regulatory affairs • Self-motivated individual with passion to succeed • Good analytical skills • Aptitude for technology • Demonstrated experience coordinating organization-wide initiatives • Experience in driving change management initiatives across an organization • Demonstrated comfort working within ambiguous environments to develop the required structure to improve the current state • Understanding of manufacturing processes and related issues • Understanding of product design and related issues Our offer This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by. Contact Find out more info about Philips at www.philips.com/na/careers Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status. #LI-HT1

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=200331&lang=en


• Location: Cleveland

• Post ID: 34461840 cleveland
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