Supplier Quality Assurance Manager
Job TitleSupplier Quality Assurance Manager
As the incumbent of the Manager, Supplier Quality Assurance 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.
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).
- Develops purchasing control processes, procedures & systems in compliance with applicable regulations
- Sets/updates purchasing control requirements to suppliers, classification of suppliers, and risk categorization
- Ensures integration and validation of purchasing procedures with supporting IT and data applications for effective operationalization
- Owns supplier qualification, audit, and assessment. This includes supporting and defending Philips in external and internal inspections/audits, and supporting the closure of regulatory compliance gaps at suppliers and suppler non-conformances.
- Participates in supplier selection process; maintain the Approved Supplier List (ASL) and documented evidence of evaluation records
- Actively monitors and reports on supplier quality metrics, quality agreements with critical suppliers, and quality of supplier records and drives supplier quality management review with relevant stakeholders
- Actively participates in supplier quality related communication and feedback
- Drives compliance with applicable Quality Management Systems; engaging in Corrective Actions as needed
- Supplier Quality Subject Matter Expert for approved Quality Agreement templates managed in Ariba Cloud
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
- Working Knowledge of medical device regulations, e.g., ISO 13485, FDA cGMP, MDD, other global equivalent
- Minimum of 2 - 4 years of quality, internal audit or purchasing controls related work experience in a regulated industry
- Bachelor's degree preferably in an Engineering, Business, or Supply Chain discipline with > 5 years of related experience
- Proven track record and Excellent in root cause analysis, corrective and preventive action methods.
- Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.
- Experience with Quality Management Systems (QMS)
- Auditing skillsets, up to and including certified SQ lead auditor training
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.
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