- 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 sigmas, 8-D, CAPA, 5WHYs.Knowledge of Good Manufacturing Practices and ISO 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.
- Experience auditing supplier is desirable.
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Sr Supplier Quality Engineer - Alajuela, Costa Rica - Philips
Descripción
Job Title
Sr Supplier Quality EngineerJob Description
Senior Supplier Quality Engineer
Implement Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain.
Your role:
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.
You're the right fit if:
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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