Supplier Quality Engineer - Reedsville, PA

Job TitleSupplier Quality Engineer - Reedsville, PA

Job Description

We welcome you to join Philips Ultrasound as an Supplier Quality Engineer in our Reedsville, PA location

In this role, you will be working with our Ultrasound product line Philips Healthcare Ultrasound

You are responsible for

  • Strong knowledge of a production facility "factory", process engineering, problem solving, manufacturing environment a must.
  • Manage Supplier Quality performance and reporting, GSRS, BRM, QR, Monthly Quality reports (FFOR, Yield, SCAR, etc..), conduct line release for assigned commodities / suppliers
  • Perform supplier QMS and other quality audits as required to confirm supplier compliance to applicable regulatory standards
  • Participate in Supply Base and Commodity Strategy Development
  • Ensures process and quality control plans are in place across the supply chain, alignment of OQC and IQCs SCN point contact for supplier. Liaison between R&D and Supplier as applicable
  • Manage supplier conformance to PQA requirements
  • Drive structural quality and process improvements, such as quality agreements, quality specifications, in collaboration with the commodity managers, R&D and SC Engineering
  • Responsible for, and leads, supplier qualification audits and capability assessments
  • Verify supplier readiness to the appropriate level of maturity, from the quality management perspective, at each milestone in a product development process
  • Ensure supplier early involvement/input into product requirements and design specifications, and supplier participation in Philips design reviews
  • Influence product development (PD) project teams to design for quality/reliability, lead collaboration between the supplier and the PD project team
  • Lead and facilitate implementation of the elements of APQP into new or existing suppliers for NPI projects with suppliers
  • Participate in the assessment, selection and technical development of new (and existing) suppliers
  • Support local factory as assigned, to:
  • Identify quality/technical issues at suppliers, drive resolution (closed loop corrective action, SCAR) with the supplier(s)
  • Execute responsibilities as prescribed in FAI, IQC, SDR, Purge, MRB, SCAR and other SQM/SQE processes
  • Work with other functional engineering disciplines as required to permanently solve technical supplier quality related problems
  • Manage other responsibilities of the SQE role
  • Support introduction of new products into existing suppliers as required for NPI projects

You are a part of

In today's challenging and changing healthcare environment, clinicians need every image to contribute to a confident diagnosis and every moment to matter in the clinical workflow.

Philips imaging ultrasound machines bring innovative solutions to clinical complexity while simplifying workflow. Our suite of Ultrasound systems Philips Healthcare Ultrasound is designed to meet the many unique challenges – you can make a difference in your new role every day.

To succeed in this role, you should have the following skills and experience

  • 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.
  • 8+ years of total industry experience with 4+ years of related experience in a medical device or regulated industry.
  • Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
  • Experience in root cause analysis, corrective and preventive action methods.
  • Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc

In return, we offer you

We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people's lives every day.

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 about the testing process Ultrasound

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.

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, and 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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