Senior Quality Engineer 1, Supplier Assurance
Job TitleSenior Quality Engineer 1, Supplier Assurance
In this role, you have the opportunity to
Provide Supplier Quality engineering support to Global supply base. The Supplier Quality Engineer will have oversight and active review and management of non-conformances, creation and review of quality metrics, and developing and maintaining effective working relationships with suppliers consistent with quality and business goals.
You are responsible for
- Develop current and future Supply base. This includes partnering with suppliers (contract manufacturers, service providers, component manufacturers) on the development, manufacture and improvement of product(s), supplier assessments, and risk analysis, provide revision and maintenance of an Approved Supplier List, create, finalize, and maintain supplier Quality Plans/Agreements, issue and investigate supplier delivery, quality, and compliance related non-conformances using a systematic approach to problem solving, conducting risk analyses and drive corrective and preventative actions to successful closure
- Provide R&D and Manufacturing Engineering (ME) project support across multiple commodities (e.g. plastics, electronics, metals and chemicals) as the resident supplier development expert. Work with suppliers to perform process and component material development work to ensure components/materials and sub-assemblies are qualified to the appropriate requirements prior to commercialization and/or design or revision changes. Work with R&D, ME and the Supplier to clarify design intent and requirements and ensure supplier feedback is included in the supplier development process
- Lead or participate in the audit and assessment of Suppliers ensuring they are compliant with associated policies/procedures and GMP/ISO/PMDA requirements. May also include due diligence audits/assessments
- Develop and maintain a Supplier Performance Scorecards, analyze and identify emerging supplier nonconformance trends using appropriate statistical tools. Report supplier quality trend data during Quality/Operations Site Review and Management Reviews
You are a part of
Global Supplier Quality programs and objectives and a will be able to provide direct support of Global Supplier Quality programs and transfer activities.
To succeed in this role, you should have the following skills and experience
- B.S. in Engineering or equivalent technical major
- 6+ years in medical device or related industry in a technical position
- 3-5 years' experience in one or more of the following: Quality Engineering, Operations Engineering and/or Research & Development in the medical device, biotech or similar industry.
- Excellent working knowledge of applicable regulations and standards such as FDA QSR, ISO 9001/13485 & MOD Knowledge in the areas of Design Controls, V&V, manufacturing practices and statistical techniques
- ISO 13485 Lead Auditor Certification
- CQE and CQA certification is desirable
- Six Sigma Black or Green belt is preferred
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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