Sr. Manager, Supplier Quality Assurance

Your challenge
As the incumbent of this Supplier Quality Assurance Manager 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).
Your Responsibilities
Your key responsibilities are in the domain of Supplier Quality management, Remediation of existing risks from internal and external audits of Supplier Quality and Purchasing Controls, supporting Supplier selection, warehousing and distribution controls, QMS qualification including supplier quality audits, approval, monitoring, feedback and communications- including Supplier Corrective Action Requests- where applicable.
+ Works as a Supplier Quality specialist, on the development of the medium term policy for supplier quality, and processes results into a supplier quality vision/roadmap.
+ Exhibit distinctive high degree of original, out of the box thinking, needed to find solutions to the assignments.
+ Formulates new supplier quality solutions by integral, original thinking and adds new supplier quality concepts/elements to his sub discipline.
+ Combines abstract ideas at a high conceptual level, and generates new types of solutions. Formulates, as a recognized supplier quality authority, solutions across multiple disciplines to effectively achieve goals together.
+ Builds actively networks with key contacts in- and outside Philips for his specialism to keep abreast of new developments/insights.
+ May lead multi-disciplinary change projects in supplier quality, managing a significant number of people. Typically requires a Master?s degree with > 5 years of related experience in supplier quality. Ensure compliance to external regulations & standards and Philips policies on Purchasing Controls
+ Responsible and accountable for establishment, maintenance and oversight of Purchasing Controls processes and systems within the Business Group PCMS
+ Defend compliance to Purchasing Controls during internal and external audits of Philips facilities
+ Provide analysis, trending and oversight of Purchasing Controls CAPA as a result of internal or external audits
+ Accountable and responsible for communicating shared supplier issues and shared CAPA on Purchasing Controls
+ Assure that Quality systems and GMP of suppliers meet Philips? and regulatory requirements (scope includes all QMS relevant suppliers of specified components, assemblies, devices, contract manufacturers, special processes, software, services, logistics providers and consultants).
+ Manage implementation and oversight of relevant warehousing and distribution controls across global economic zones of business for PCMS (pursuant to applicable regulations, & Philips standards/specifications).
+ Responsible and accountable for maintaining the Approved Supplier List including the supplier master file for compliance with 21 CFR 820.50 and equivalent global QMS requirements (e.g., ISO 13485 sec 7.4).
+ Responsible for ensuring compliance (and validation) of Purchasing Controls applications in collaboration with IT and Procurement.
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.
We are looking for
+ Proficient knowledge and understanding of Purchasing Controls procedures and processes per ISO 13485, cGMP
+ 5+ years? experience of supplier management experience for devices (for and/or drugs and cosmetics HW BG).
+ 5+ years? experience of purchasing controls and supplier management experience for medical devices or other regulated industries.
+ Experience with quality systems, quality tools and methodologies, including Critical to Quality, FMEA,
+ Root Cause Analysis , Pareto, 8-D, 5 Why, Statistical Methods for sampling, design of experiments.
+ Familiarity with FDA Product Listing and site registration requirements (and equivalent MDD requirements).
+ Expert/Proven auditing skills, experience with auditing suppliers, lead auditor certification is a plus.
+ Knowledge of labeling and packaging requirements
+ Front room audit experience
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.
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. 76ac68d3294c41228a421838f8b2092b

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