**World renowned Cellular Performance Institute looking for a clinical and laboratory quality coordinator.**
The Cellular Performance Institute, located in Playas de Tijuana, is looking for a clinical and laboratory quality coordinator responsible for supporting the development, implementation, and maintenance of quality management systems (QMS) to ensure compliance with company standards, industry regulations, and customer requirements. This role involves conducting audits, analyzing quality data, assisting in process improvements, and collaborating with various departments to promote a culture of continuous quality improvement.
We are considered by many to be the world’s premiere facility for stem cell treatments and manufacturing. Our weekly stream of clientele include professional athletes from the UFC, NFL, MLB and more.
**Requirements**:
- Bachelor’s degree in health sciences (Medicine, Nursing, or related fields) and/or Law (If the degree is in Law, it is essential to have studies or verifiable experience related to health regulation, quality management, or related areas).
- Conversational English is required.
- Quality Management Systems (ISO 9001:2015).
- Internal or external audits under ISO 9001:2015 standards.
- Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
- National health regulations (NOMs, COFEPRIS) and international regulations (FDA, CAP).
- Development of Standard Operating Procedures (SOPs), change control, CAPA, and root cause analysis.
- Good documentation practices.
- Knowledge of regulatory processes and procedures before authorities such as COFEPRIS, SEMARNAT, PROFEPA, among others (submissions, responses, obtaining and maintaining licenses, notices, and corresponding permits).
**Preferred Education**:
- Postgraduate studies such as a specialization, master’s, or doctorate in: Hospital administration,



Health regulation or health legislation, Quality management, Public health or related health sciences.
- Additional desirable experience in clinical trials, management, and follow-up of procedures before COFEPRIS, as well as direct or indirect participation in the implementation and development of these studies.
**Responsibilities**:
- Implement and oversee quality processes within hospitalization, clinical laboratory and cellular laboratory areas, performing the following activities:
- Monitor and ensure normative compliance and national/international quality standards,
- Assist in developing, implementing, and maintaining QMS in compliance with ISO, FDA, or other industry standards.
- Maintain and update quality documentation, procedures, and policies.
- Conduct internal quality audits and assist with external audits.
- Ensure compliance with regulatory requirements and company policies.
- Support corrective and preventive action (CAPA) processes.
- Identify opportunities for process improvements and recommend corrective actions.
- Analyze quality data and trends to enhance product and service quality.
- Coordinate quality training sessions for employees.
- Maintain quality records and prepare reports on quality performance metrics.
- Assist in investigating customer complaints and non-conformance issues.
- Work with cross-functional teams to address quality-related issues.
**Schedule**:
- Monday to Friday 8am to 5:30pm
**Salary**:
- $37,801.20 MXN before taxes monthly
**ABOUT US**
Pay: $37,801.20 per month
Application Question(s):
- Do you live in Tijuana?
**Education**:
- Bachelor's (preferred)
**Experience**:
- QMS ISO 9001:2015: 2 years (preferred)
- National and international health regulations: 2 years (preferred)
- verifiable experience: health regulation, quality management: 2 years (preferred)
**Language**:
- fluent English (preferred)
Work Location: In person

📌 Clinical and Laboratory Quality Coordinator (Tijuana)
🏢 Cellular Performance Institute
📍 Tijuana