Senior Quality Engineer 1, Supplier Assurance
Job TitleSenior Quality Engineer 1, Supplier Assurance
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 Senior Supplier Quality Engineer will be responsible for providing Supplier Quality engineering support to Global supply base. Position will directly support Costa Rica Supplier Quality programs and objectives and provide direct support of Global Supplier Quality programs and transfer activities. 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.
- 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 non-conformance trends using appropriate statistical tools. Report supplier quality trend data during Quality/Operations Site Review and Management Reviews
Specific Skill Requirements:
- B.S. in Engineering or equivalent technical major
- 6 – 8 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
- Must be able to handle supplier situations and interactions in a tactful, professional and effective manner.
- Thorough knowledge of CAPA and Root Cause Investigation best practices.
- Ability to lead others with a proactive attitude.
- General knowledge of Program and Project management to include Critical Chain.
- Ability to work within a team or independently.
- Ability to represent the Corporation on a professional level during onsite site assessments/interactions with Suppliers.
- Ability to manage multiple and/or complex projects and priorities under deadlines.
- Ability to apply knowledge with an understanding of business operations to achieve regulatory compliance is needed.
Licenses and Certifications:
- ISO 13485 Lead Auditor Certification
- CQE and CQA certification is desirable.
- Six Sigma Black or Green belt is preferred.
Additional Desirable Requirements:
- Injection Molding knowledge and experience in Operations or Supplier Quality area is desired
- Strong verbal and written communication skills, internal and external to the company.
- Well-developed presentation and interpersonal skills.
- The ability to influence and negotiate at all levels of the organization.
- The ability to prioritize multiple competing deliverables simultaneously.
- External supplier Quality System auditing experience.
- Computer Skills (MS office, statistical analysis software, PLM, ERP and QMS)
- Familiar with measurement equipment used for incoming quality inspection
- Ability to travel 15% of time both domestic or international
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.
Call to Action:
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Ready to start improving lives by putting your personal skills & passions to work? Apply Today!
Find out more info about Philips at www.philips.com/na/careers
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.
In case of difficulties with your job application please send an email to [email protected]
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