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Philips Sr Supplier Quality Engineer 
Costa Rica 
525498151

24.06.2024

Responsibilities

  • Completes Qualification of raw material and components (including spare parts), development/ improvement of supplier processes for CtQ’s, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
  • Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
  • Ensures that the components/products at the supplier (including spare parts and services) are released according to agreed specification and quality requirements (APQP / PPAP) and SQ audit results.
  • Executes SCAR management, effective and timely closure.
  • Execute Non-Conformances evaluation regarding to raw material.
  • Lead or participate in the audit assessment of supplier ensuring they are compliant with associated policies/procedures and GMPs requirements.
  • Independently produces and completes Supplier Quality Engineering related activities and documentation.

Requirements

  • Bachelor’s degree in an engineering or a combination of equivalent job experience in related field,
  • 3-5 years in medical industry in areas related to Quality Assurance, Incoming Quality, or Complaints.
  • Advance English level.
  • Knowledge in: problem solving with quality tools such as: 6 sigma, 8-D, CAPA, 5WHYs.
  • Knowledge of Good Manufacturing Practices and ISO 13485. CAPA system, as well global medical device regulation standards such as: 21 CFR parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive.
  • Root cause analysis, corrective and preventive action methods. Product/quality development methods: CtQ definition, DfSS, SPC, APQP, FMEA, control plans.
  • Administrative shift

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