Sr. Supplier Quality Engineer

Job Title

Job Description

Senior Supplier Quality Engineer

Responsible for providing Supplier Quality engineering support to Global supply base. Position will directly support Costa Rica Supplier Quality programs and objectives and provide direct support of Global Supplier Quality programs and transfer activities. 

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:  

• Bachelor’s degree in an engineering or a combination of equivalent job experience in related field,

• You've acquired 3+ 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.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.  

• Administrative shift

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