Detalle de la Oferta

Descripción de la Oferta

JOB SUMMARY
This position will support the sustaining of the Quality System for the Plant. Responsible for the development, recovery and maintenance of the documentation related to Quality Management System and Regulatory Compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES

- Guarantee full compliance of all the ACA, CAPA and Customer Complaint investigations.
- Follow up of open Quality Figures (ACA, CAPA\u2019s, Customer Complaints and PA).
- Serve as a coach to the Investigator during the investigation process.
- Coordination and Measurement of the activities related to the maintenance of the Quality Management System, including quality figures.
- Maintain metrics for the Plant regarding all quality figures.
- Assists in the Plant preparation for External Audits, as required.
- Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485), CFR Part 820, Problem Solving methods, and that documentation is complete and compliant with requirements.
- Observes all company rules, regulations, and procedures such as safety and housekeeping (6\u2019s).
- Comply with Good Manufacturing Practices
- Participates as part of the Internal Auditors Team, as required.
- Provide support to the activities of the Release area, as required.
- Responsible that his/her payroll clock punches are registered before entering or leaving, following and accepting company payroll policies.
- Responsible of performing as per Job Description\u2019s SOP\u2019s and work instructions.
- Attends all requested training or company meetings.
- May participate in internal committees as Safety, improvement events, etc. as required.
- Comply and follow all procedures within the company's safety policy.
- Support all Environmental, Health and Safety (EHS) programs and initiatives in order to support our zero accident culture.

EDUCATION & EXPERIENCE REQUIREMENTS

- High school diploma required.
- Minimum three (3) years of equivalent job experience.