Strategic Supplier Quality Engineer
7 dagen geleden

Job Description

In this role, you have the opportunity to

serve the Diagnostic Imaging global supply chain management to drive quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized.

You will lead with best practices to enable our organization to provide high quality medical products to our customers. The role will manage activities downstream related to purchased part qualification with suppliers, supplier quality issue resolution and ensuring appropriate incoming material inspection strategies.

You will improve product quality by working in collaboration with suppliers and internal stakeholders including manufacturing operations, procurement and R&D.

Using your technical expertise and knowledge of quality improvement tools you will offer solutions to at times complex quality issues to minimize delays in production and prevent reoccurrence.

You are responsible for

  • Monitoring Supplier Product Quality Trending in Operations and lead supplier improvement projects in cooperation with QE, Strategic SQE, R&D, Q&R, Procurement, Operations Quality Management etc.
  • Managing and solving product quality issues that have high impact assessment result, by using 8-D methodology with Suppliers (SCAR).
  • Deploying 8-D knowledge and GDP to ensure complete, effective and self-explaining records for non- conforming products registered with QN and SCAR.
  • Gathering required information to lead, report and drive action progress for monthly Supplier Performance Meeting.
  • Supporting Quality Engineers to identify and assess cost impact for Philips and safety impact for the end customer, patient and personnel
  • Monitoring and approving SCAR request before SCAR handover at D3 step to Strategic SQE.
  • Ensuring continuously feedback and required escalations to Strategic SQE and Supplier Quality Manager on Supplier Quality issues in order to drive continuous improvement.
  • Leading the monthly SCAR review meeting together with Q&R, Strategic SQE and Operations QA to monitor and evaluate the FDA compliancy, the effectiveness and the harmonized way of working in execution and documenting the SCAR process.
  • Supplier Selection, Classification and Approval

  • Partner with Procurement Engineering and Advance Quality Engineering to complete supplier selection, classification and qualification activities for New Product Introduction
  • Partner with Procurement Engineering to maintain the Supplier Master File / Approved Supplier List
  • Partner with R&D and Advance Quality Engineering to evaluate supplier manufacturing capabilities and maturity
  • Partner with R&D and Advance Quality Engineering to manage New Product Introduction into supplier facilities / manufacturing environment using APQP or PPA elements
  • Strategic, Corporate, & Functional Directives

  • Continuous improvement effort to establish One QMS
  • Lead strategic supplier improvements (e.g., Raven Projects)
  • Support cross-functional teams responsible for managing EU MDR activities
  • Support global rollout of Supplier Quality process improvements (e.g., APQP)
  • Support global rollout of Supplier Quality IT tools (e.g., MetricsBus, Trackwise)
  • Support Supplier Quality Hoshins
  • Support Business Review Meetings
  • Facilitate Purchasing Controls related CAPA
  • Facilitate activities related to supplier De-risking
  • Part Qualification

  • Partner with Design Engineering and Advance Quality Engineering to determine Part Qualification requirements and complete supplier design transfer
  • Partner with Advance Quality Engineer to plan special process validation activity
  • Complete Part Qualification / Special Process validation activities
  • Develop Receiving and Inspection Plans
  • Conduct planned Supplier Audits / Assessments
  • Audits and Assessments

  • Conduct planned Supplier Audits / Assessments
  • To succeed in this role, you should have the following skills and experience

  • Master’s or Bachelor’s Degree in math, statistics or engineering with at least 3-5 years of experience in Supplier Quality Engineering
  • Experience in Quality Tools and Processes (e.g., GD&T, APQP, DFMEA, PFMEA, PPAP, VOC, SPC, 8D, 6σ, etc.)
  • Knowledge and experience in Medical Device, IVD, Aerospace or Automotive Industry is a must-have requirement; Industry Standards for Validation;
  • Industrial Statistics, Federal cGMPs & QSRs, ISO 13485, Risk Management regulations and application (ISO14971)

  • Project Management experience and Six Sigma Certification (preferred)
  • ASQ Certified Quality Engineer (preferred)
  • Strong analytical aptitude (i.e. statistical techniques, database development) and the ability to interface with top organizational leadership as well as internal and external customers
  • Ability to communicate effectively (in English) and to influence positive change effectively
  • Exceptional conflict-resolution skills are
  • 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.

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