Full Time Employee
- Contributes to the development and implementation of strategies and initiatives to support the CAPA (Corrective and Preventive Action) and Audit Quality Programs, ensuring alignment with medical device regulations, standards, and company objectives.
- Primary responsibility includes maintaining and improving CAPA and Audit Quality Program activities. This role requires solid experience working in regulated environments (e.g., ISO 13485, 21 CFR Part 820, 21 CFR Part 11) and proficiency in using electronic Quality Management Systems
- Create and Maintain yearly Internal Audit Program.
- Support the coordination and readiness for External Audits (Customer, Notify Body, Inspections, etc.)
- Help to ensure the Company is prepared for internal, external and/or customer audits and inspections.
- Participate in the development and maintenance of the Internal Lead Auditor Certification program.
- Contributes to organizational change to create and sustain a work environment conducive to continuous improvement.
- Monitoring and maintaining CAPA activities and Program.
- Assist in CAPA investigations and follow-up actions as needed.
- Provide guidance and support to team members on internal audit and CAPA processes.
- Work on multiple Quality System projects simultaneously.
- Communicates effectively across teams to explain methodology, process, and results from analysis.
- Evaluate the accuracy and conformance to required procedures and performance improvement projects and initiatives.
- Participate in CAPA Board Meetings and provide input on quality issues and trends
- Prepare quality documentation, metrics, and reports by collecting, analyzing and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions and re-validations.
- Schedule Management Review Meeting (s)
- Support to prepared Management Review presenta
📌 Quality Systems Engineer (Tijuana)
🏢 Corza Medical
📍 Tijuana
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