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Posted: Wednesday, March 8, 2017 6:29 AM

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. 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: Manage complaint handling system including performing as Process Owner, Head of the Supervisory Organization responsible for post-market surveillance, and responsible for that Cost Center budget. Manage activities related to defining, launching and managing activities associated with Field Corrective Actions and Field Safety Notices. Provide the key point of contact for Competent Authorities and Notified Bodies for issues related to the performance of the product in the field including Field Actions. Collect and report on the performance of the SRC products in the field. Establish and manage to KPIs related to: Timely completion of complaint investigations Timely reporting of adverse events Efficiency of the Post-market surveillance components of the quality system Effectiveness of the Post-market surveillance components of the quality system Provide post-market performance data to the Product Teams for the purpose of design improvements Ensure alignment between the SRC post-market processes with Philips Quality Management System Participate as a Business Process Expert with the development and implementation of the post-market surveillance components in the Philips Quality Management System. Participate with the rest of SRC Quality Leadership Team in providing an effective and efficient SRC Quality Management System. 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. The post-market surveillance team is responsible for monitoring, investigating, tracking and reporting on the performance of all SRC products in the field primarily through the management of the Complaint Handling System. They are responsible for reporting individual complaints as described in the Medical Device Reporting and Medical Device Vigilance systems as well as similar reporting structures worldwide. Should the need arise, the team is responsible for the management of any Field Corrective Actions or Field Safety Notices. Location: New Kensington, PA 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. Specific skill requirements for this role include: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required: • Require 10 years working in a regulated environment in quality systems, manufacturing, product development, regulatory compliance, and/or quality engineering. Preferably 5 years working in FDA regulated environment. Preferably 5 years working with complaints management/post-market surveillance. • Skills in team leadership and working on teams. • Experience with process improvement, six sigma, lean manufacturing, or equivalent. • Experience managing regulatory body site inspections. • Balance regulatory compliance with business objectives using a risk-based approach. • Effective at making plans, decisions, and working in a dynamic environment where priorities can change and interruptions occur on a regular basis. 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. 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-MH1

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=214104&lang=en


• Location: Pittsburgh

• Post ID: 37141030 pittsburgh
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