Detalle de la Oferta

Descripción de la Oferta

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 the CAPA and Complaint Management System and Regulatory Compliance. Responsible for the Management of the CAPA and Complaints.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

- Guarantee full compliance of all the CAPA and Complaint investigations.
- Follow up of open CAPA\u2019s , Complaints and NCMRs.
- Serve as a coach to the Investigator during the investigation process.
- CAPA SME
- Coordination and Measurement of the activities related to the maintenance of the Quality Management System, including Customer Complaints and CAPA\u2019s.
- Maintain CAPA and Complaints metrics for the Plant.
- Assists in the preparation for External Audits.
- Manage the Document Creation in the applicable system related to the process under responsibility.
- 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.
- Support the internal supplier third party and FDA quality audits.
- Support all company safety and quality programs and initiatives.
- May perform other duties and responsibilities as assigned.
- Support all company safety and quality programs and initiatives.
- May perform other duties and responsibilities as assigned.
- Provide support to all Safety, Health and Environment (EHS) programs and initiatives in order to support our zero accident culture.

MINIMUM REQUIREMENTS

- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
- Good knowledge of CAPA and Complaint Investigations
- Bilingual English speaking and writing
- BS degree or equivalent
- 4+ years of experience in CAPA and complaint investigations.
- Good knowledge in ISO 13485 and CFR Part 820
- Or an equivalent combination of education, training or experience.