Philips Sr Supplier Quality Engineer 

Costa Rica 

525498151

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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