Supplier Quality Engineer
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.
The PCMS Global Supplier Quality Team works with a worldwide supply base and our global Business Innovation Units (BIU's) to help ensure high quality purchased materials. The team leads Supplier Quality Engineering activities during new product development, purchased material quality issue resolution and ongoing supplier quality monitoring.
Perform Supplier Quality activities related to purchased part qualification with suppliers, supplier quality issue resolution and ensuring appropriate incoming material inspection strategies. Drive quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized. Lead with best practices to enable our organization to provide high quality medical products to our customers.
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).
Manage Supplier Quality related activities for purchased materials for electro-mechanical commodities such as printed circuit board assemblies (PCA's), power supplies, cables, battery packs, plastics, sheet metal, machined parts, OEMs (displays, medical assemblies), labeling, etc. Focus is on quality issue resolution via an 8-D based Supplier Corrective Action request process. Resolve quality issues via structured quality methods in order to ensure efficient and effective root cause analysis, corrective actions and preventive actions that ensure there is no recurrence. Work with suppliers to ensure all necessary quality activities are rigorously addressed during initial product release and change such as: process mapping, process FMEA, process control plan, process validation (IQ, OQ, PQ), GR&R,MSA, line release, etc.. Ensure supplier test strategy aligns with quality goals. Execute audits, CAPA's and monitor metrics. Orchestrate Philips first article inspection / first production inspection, and ongoing inspection plans that are aligned with supplier's capabilities, quality history and our product needs.
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 the world.
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 for the billions of people our brand touches each year.
Specific skill requirements for this role include:
- BS Engineering degree and minimum of 7 to 10 years industry experience in manufacturing of electro-mechanical systems/products/solutions for the medical, aerospace or automotive industries
- Demonstrated knowledge of manufacturing processes for commodities such as printed circuit board assemblies, power supplies, cables, custom battery packs, mechanical parts (plastics, machined, sheet metal), cables, etc.
- Experience with all aspects of supplier quality management: quality concepts/tools/methods (e.g. FMEA, DOE, IQ/OQ/PQ, MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures.
- Knowledge of the Purchasing function and associated commodity, supply base, quality and data management considerations. Understanding of Procurement, Supplier Relationship Management, Material and Supplier Quality and Data Management areas.
- Effective communicator. Able to work effectively with global, cross-functional stakeholders.
- Experience in a regulated environment, medical preferred.
- Certified auditor for ISO13485 or 9001.
- Knowledgeable in SAP Quality Management, Oracle Data Warehouse, Mini-Tab, Query tools such as Business Objects, web-based systems, and MS Excel (power user).
- Six-sigma Black Belt or Green Belt.
- Fluent in English, as well as language within region.
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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