Quality Engineer

hace 3 semanas

Ciudad Juarez, México Emprego MX A tiempo completo

**EMPRESA IMPORTANTE**

**Solicita**:
**Quality Engineer**

**Descripción y Requisitos**

**POSITION OVERVIEW**: Quality engineer directs and participates in quality assurance efforts to ensure that the Company products and services conform to specified quality standards and regulatory requirements. Performs all activities associated with the QMS with focus on Internal Audits, RMA, NCMR and CAPA processes.
- The Quality Engineer position has an integral role in analyzing quality and operational data, identifying trends, preparing reports, and managing key aspects of the quality system that may require direct interaction with customers, suppliers and auditing bodies.**ESSENTIAL DUTIES and RESPONSIBILITIES**, includes the following responsibilities, but not limited to:

- ? ISO knowledge certification
- ? Quality Management Review
- ? Quality System
- ? Works with suppliers and customers in resolving quality issues with non-conforming materials and assemblies through corrective and preventive action processes.
- ? Performs internal audits of core processes within the company. ? Performs technical oversight for inspection and test activities and develops and improves inspection techniques.
- ? Manages MRB process and ensures non-conforming product has been dispositioned in accordance with applicable QMS and regulatory requirements.
- ? Establishes root cause and appropriate Corrective/Preventive Action to eliminate existing or potential non-conformance conditions.
- ? Provides necessary training for inspection and production personnel as may be required.
- ? Works directly with Product Engineering and Operations personnel to address corrective actions and out-of-control events. ? Creates and submits Engineering Changes, Drawings, Procedures, Rework Instructions and Variance Authorizations as required.
- ? Participates and supports process development as related to supplier development/qualification, quality processes/tooling, and risk management activities such as FMEA.
- ? Develops and coordinates execution of process validation protocols and reports ensuring proper statistical analysis is applied. ? Develops analysis methods for determining reliability of components, equipment, and processes. Acquires data and performs analysis of data for reporting quality system metrics.
- ? Applies statistical and QE tools such as SPC, DOE, Hypothesis testing, R&R cage studies. Collect data, review and publish monthly key performances indicators and other metrics.**PREFERRED QUALIFICATIONS AND EXPERIENCE**
? Bachelor's degree preferred.
- ? 2 years minimum medical device or contract manufacturing support in Quality department.
- ? Experience in root cause analysis, material disposition and corrective action activity required
- ? PFMEA/SPC/Statistics/Validation experience is a plus.
- ? Knowledge or training of IPC WHMA-A-620B, ISO 9001:2008 and ISO 13485:2003
- ? Bilingual English/Spanish speaking.
- ? Communication and written skills.
- ? People and interpersonal skills.
- ? Strong operations and computer systems.
- ? Proficient in Microsoft programs word, excel, outlook, PowerPoint, etc.
- ? Must be well organized and detail oriented with the ability to meet deadlines.
- ? Confidentiality and integrity a must.
- Puesto: Calidad**Información Adicional**
- Tipo de contrato: Permanente- Salario: Negociable
- Pais: MEXICO
- Estado o Region: Chihuahua
- Ciudad: Ciudad Juarez

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