Director, Supplier Quality Assurance

Your challenge
As the incumbent of this Director of Supplier Quality 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
+ Manage Supplier Improvement and ensure Purchasing- and Supplier- management compliancy to FDA QSR 820 par 50 Purchasing Controls and ISO13485 section 7.4 Purchasing Controls
+ Develop and mentor SQA direct reports
+ Develop and implement Supplier Quality and Purchasing Controls processes, including linkages to Global Sourcing strategies and NPI that address the present and future needs of our internal and external customers
+ Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets; Lead and manage assigned BG or Global SQA initiatives in partnership with critical stakeholders Execute as the regional SQA lead in Markets when requested, aligning with BG SQA, SQE & SDE leads
+ Contributes to developing a quality assurance strategy in line with supply management and business strategy with a 3-5 year sight line
+ Assure execution of Quality oversight of Project book across BG as assigned (PH)
+ Assure harmonized processes and systems are deployed to perform Qualification of suppliers? QMS to the relevant medical device /drug (where applicable) quality regulations, and accountable for their placement on the Approved Supplier List (ASL), including required Purchasing Data elements of Supplier Master File; ensure processes for Project book oversight per RACI (PH) are established and executed.
+ Participates in the Supplier Selection process for the quality management systems aspects (QMS capability)
+ Ensure robust supplier monitoring processes are deployed per established RACI and report key KPIs per established processes
+ Accountable for and leads the process for quality audits, re-audits and performance management at suppliers Accountable to drive Supplier QMS Qualification/re-qualification (NPI/DfX/Legacy)
+ Accountable to ensure BG process for SQ KPI reporting are effectively deployed and operationalized, including reporting L1 metrics
+ Improve/develop quality management systems (supplier process improvement) at selected suppliers per business needs
+ Develop purchasing controls processes and procedures, including those for BOM, non-BOM, services, spare parts and Markets, including their connection to other critical QMS processes such as Design Controls, Production and Process Controls, Traceability, Distribution, Complaint Handling, Installation, Services, 3rd party product risk assessments & Software
+ Ensure continual improvement of the effectiveness of purchasing controls and supplier quality processes and procedures, including regular oversight over establishment and execution of Quality Agreements
+ Accountable and responsible for preparing for and defending Purchasing Controls of BG or Market in inspections by external agencies or internal Philips audits of Purchasing Controls processes
+ Manage and oversee BG Purchasing controls CAPA, including root cause identification, trending, shared CAPA and effective and timely closure;
+ Direct and manage the communication of critical shared BG and/or Market issues with broad SQA team for corrective and preventive actions
+ Direct the development and delivery of training programs to internal teams and suppliers on Philips Purchasing controls; Supports on-site/off-site supplier quality development including coordination of required resources
+ Coaches and trains the SQ team in developing competencies and capabilities per procedures
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
+ 10 - 15 years? experience in the medical device industry, with progressively responsible experience leading quality assurance organizations, preferably in supplier quality
+ Bachelor?s degree in engineering field and 5 years related quality/supplier quality engineering experience
+ Master degree or higher in engineering field preferred
+ Risk Management; comfortable applying risk methodologies as outlined in ISO 14971 and making risk based decisions
+ Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically
+ Project planning and management
+ Logical cognitive skills and ability to apply scientific methods
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. c0c5157f9da24b5a855f930d44498366

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