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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 (eQMS).

What we value

Customer First: We deliver extraordinary experiences.
Accountability: We do what we say
Integrity: We do what is right
Inspired: We love what we do
One Integral Team: We before me, always

What You Will Do (job Duties)

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

📌 Quality Systems Engineer (Tijuana)
🏢 Corza Medical
📍 Tijuana