Quality Engineer

hace 2 semanas


Tijuana, México North American Production Sharing A tiempo completo

Company dedicated to performing medical assemblies located in the Pacific area is looking for a Quality Engineer:
**Position Summary**

This position will assist with the ongoing monitoring, support, and continued improvement of QA Production processes and related activities and conduct periodic audits to ensure compliance and controls of the production processes.

**Essential Duties and Responsibilities**
- Implement statistical methods to inspect, test and evaluate the reliability of manufacturing and QA control processes, products, and production equipment.
- Determine quality improvement factors and improve QA Production SOPs and DHR forms.
- Implement and improve process controls to ensure on-time detection of potential product Quality issues and determination of appropriate follow up actions.
- Work with CAPA owners to complete investigation activities, determine root cause and implement appropriate Corrective and Preventive Action.
- Participates in the development of Validations (IQ, OQ, & PQ) for equipments, related with new products and/or manufacturing lines.
- Evaluate Non-Conformance records (NCMR’s) and support resolution of Quality issues.

**Requirements**:

- 2 years of experience (Medical Industry)
- Bachelor’s Degree in engineering or equivalent education
- Advanced english
- Current VISA
- IQ, OQ, PQ Validations
- Certified quality auditor, quality engineer or six sigma green belt (desirable)
- ISO 13485 and 21 CFR 820 (novice)
- GMP´s and GDP´s
- CAPA's/COR's/NCMR's & Complains


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