Quality and Regulations Manager

hace 2 semanas


Ciudad Juarez, México HAT Talent Search A tiempo completo

**Quality / Regulatory Manager**

**Mandatory: Experience in Medical Devices**

Manufacturing Company located in Ciudad Juarez is searching for a **Quality Manager**. The incumbent will be responsible of directing, planning, organizing and controlling overall management of Quality site activities related to customer quality, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by the clients and in compliance with the ISO 9001: 2015 and, ISO 13485, Administer Quality Management System (QMS), Manages the site regulatory requirements for compliance, certifications, local state federal and international regulations as required. Responsible for internal and external audits. Drive corrective and preventive actions, monitor the implementation and effectiveness of the actions. Administer KPI’s to improve customer satisfaction.

**EDUCATION / EXPERIENCE REQUIREMENTS**:

- B.S. Degree in Engineering, or other related science. / MBA a Plus.
- Green/Black Belt 6 Sigma, Lean Certification a plus.
- Bilingual: English - Spanish.
- Over 10 years’ experience in Quality field for medical devices processes.
- Experience In Medical Devices Industry Quality Standards; ISO 9001, ISO 13485, FDA.21 CFR820.
- Certification as Auditor Leader in ISO 9001 & 13485 desirable.
- Core Tools: Control Plans, SPC, Validations and related documentation.
- Customer complains management, Strong analytical problem-solving techniques: (8 steps, 8D’s, 5W, PDCA, Ishikawa DMAIC).
- Application of statistical tools, DOE, SPC, REDX, Normality Study, CPK, Product traceability.
- Management of Customer Score Cards, Knowledge of the Warranty process.
- JD Edwards or an ERP system experience is a plus.
- Development of New Products and Relationship with Suppliers and Customers and Regulatory Agencies / Health Authorities_**.**_
- Advanced MS Office skills
- Excellent Organizational and Planning skills, problem-solving, collaboration and project management skills.

Tipo de puesto: Tiempo completo

Salario: A partir de $1.00 al mes

Horario:

- Turno matutino

Lugar de trabajo: Una ubicación

Fecha límite para postularse: 30/03/2023


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