Supplier Quality Engineer

24 Oct 2024

Vacancy expired!

Job Title Supplier Quality Engineer

Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

to be a member of the a global SQE Team of Healthcare Informatics to manage mainly Software and Service suppliers in terms of purchasing controls to ensure excellent product quality and compliance. You own the implementation of Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain of the assigned business categories

You are responsible for

  • You will partner with R&D, Privacy & Security, Operations and Procurement Engineering to actively engineer quality and ensure compliance for components, Software, finished products etc., from suppliers.
  • Developing and supporting regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
  • You will lead additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records.
  • Ensuring raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements.
  • You will drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements.
  • Driving shared accountability across stake holders to design, manufacture and distribute products right the first time from our supplier base.
  • You will drive product implementation/Changes/Transfers accordingly the Philips requirements (NPIs, PDLM, APQP)
  • You will be responsible to managing SCARs, supplier QN's, unintended disruptions, and resolve supplier issues to business and regulatory compliance satisfaction.
  • Performing of Supplier Audits and leading Supplier Quality Improvement programs.
  • Leading the implementation of robust purchasing controls for the assigned business categories.

You are part of

The Supplier Quality Engineering team. This role is located in Cambridge/ MA in North America in/partially homebased. You will support the Radiology io Informatics (RI) and PD Ventures business categories as upcoming acquisitions. This is a great opportunity for growth with new challenges in the Supplier Quality domain.

To succeed in this role, you should have the following skills and experience
  • Able to work in global cross functional Teams Project Management, especially to managing NPI projects (APQP) in particular for Software.
  • Bachelor's degree in an engineering or science discipline, or equivalent experience.
  • Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course.
  • 6+ years of related experience in a medical device or regulated industry.
  • 4+ years of Project management experience
  • Working knowledge of appropriate global medical device regulations, requirements, and standards such as FDA 21 CFR Purchasing Controls 820, ISO13485, ISO14971, IEC 62304, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282) and ISO 9001.
  • Expert level knowledge of methodologies, tools and techniques in Purchasing, Operations and SQE including due diligence processes.
  • Experience in Software Development (IEC 82304) is a plus.
  • Preferred to have broader experience including procurement, manufacturing engineering and project engineering.
  • Excellent commination skills and experience in performing of Supplier Audits.

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.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran

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