Philips Senior Quality Engineer 1, Supplier Assurance in San Diego, California

  • 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

MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:

  • 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

LICENSES AND CERTIFICATIONS:

  • ISO 13485 Lead Auditor Certification

  • CQE and CQA certification is desirable.

  • Six Sigma Black or Green belt is preferred.

ADDITIONAL DESIRABLE QUALIFICATIONS:

  • 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

SKILLS AND ABILITIES:

  • 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.

PROBLEM SOLVING AND DECISION MAKING:

  • Familiar with 7-steps problem solving or equivalent tools.

  • Ability to collect, analyze, interpret and draw conclusions from data.

  • Ability to develop written protocols and keep accurate detailed records of results.

  • Ability to improvise when needed to overcome obstacles encountered in performing non-routine experiments.

  • Creative and flexible in achieving objectives.

Travel

Ability to travel 15% of time both domestic or international

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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.