Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Position Summary

The Quality Manager is an on-site leadership role responsible for ensuring the effectiveness of the site's Quality Management System (QMS) while providing strong, hands-on Quality support to manufacturing operations. This position leads the site Quality team and is accountable for maintaining compliance, driving Quality performance, and fostering a culture of continuous improvement and Quality ownership throughout the organization.

The Quality Manager provides leadership and oversight for key Quality System activities, including audits, Corrective and Preventive Actions (CAPA), complaints, nonconformances, and related Quality processes, while ensuring that the Quality organization is actively engaged on the manufacturing floor.

Working closely with Operations, Engineering, Supply Chain, and other site functions, the Quality Manager and their team will identify and resolve Quality issues,



improve manufacturing performance, achieve Quality KPIs, reduce recurring problems, and strengthen processes that consistently deliver products meeting customer and regulatory requirements.

Key Responsibilities

Quality Management System
- Lead and maintain effective site Quality System processes in accordance with applicable regulatory requirements, industry standards, and company policies and procedures.
- Provide oversight and governance for CAPA, complaints, nonconformances, deviations, change control, and other applicable Quality System processes.
- Ensure Quality System records are appropriately investigated, documented, risk-assessed, and completed within established timelines.
- Monitor Quality System health and identify systemic trends, recurring issues, and opportunities for improvement.
- Ensure appropriate root cause analysis and corrective actions are implemented and verified for effectiveness.
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📌 Quality Manager (Tijuana)
🏢 Thermo Fisher Scientific
📍 Tijuana