**OBJECTIVE**: Develops and maintains procedures that are required for processes to achieve and maintain the System Quality Standards, ISO Standards (ISO 13485) and FDA Standards such as Class I (& Class II) when needed. Coordinates continuous improvement activities such as process improvement projects in addition to internal audits and corrective and preventive action systems.
**MAIN FUNCTIONS**:
- Responsible for quality system for the company, including but not limited to developing and maintaining the manual and procedures to meet quality standards, maintaining quality records, evaluate process quality data and customer claims and engaging in continuous improvement efforts.
- Is Responsible for developing and updating procedures to meet and maintain Internal and International Norms, and Coordinates efforts to Update Quality Systems: Training, Communicating new Norms, Changes in Documentation, etc.
- Coordinates Continuous Improvement Efforts with all areas in the company in response the Results from Internal Audits as well as Corrective and Preventive Actions.
- Interact with other sites to discuss quality standards and align criteria for specific customer quality requirements.
- Responsible for informing the Performance of the Quality System by using the standard reporting process and developing new reports as needed.
- Prepares the Internal Audit Program to verify the effective Documentation and Implementation of the Procedures as well as the Follow up Audits to verify Corrective Actions results.




- Participates in the Product or Process Validation to document Changes and Improvements within the Process. Provides Support for New Product Introduction.
- Coordinates the preparation activities to receive the External Audits to achieve or renew the Certification.
- Participates in the Training of Quality Standards Fundamentals for Employees in the Company
- Supports the different Areas in the Development and Improvement of Quality Systems Documentation. Distributes Controlled Copies of the new versions of Documents, Retires Outdated Versions and Keeps Custody and Control on the Originals.
**EDUCATIONAL REQUIREMENTS**:
- Engineering Degree (Industrial, Bioengineering, Mechanical or related)
- Lean / Six Sigma Green Belt. (Black Belt Desirable)
- Certified as a Lead Auditor by a Certification Company (ASQ) Desirable.
**EXPERIENCE REQUIRED**:
- 3 to 5 Years within the quality area and the ISO 9000 Certification Process.
**LEVEL OF ENGLISH FLUENCY**:
- Technical Reading and Conversation (Advanced)
**COMPUTER USAGE**:
- OFFICE: Word, Excel, Power Point
- Application Programs (ERP systems, Statistical Software desirable)
- Documentation and/or Corrective Actions Software.
**SKILLS**:
- Proven experience with quality assurance/control.
- Demonstrates excellent written and oral communication skills.
- Possesses strong analytical, planning, and project management skills.
- Ability to work with testing equipment and maintain accurate documentation records.
Work Location: In person

📌 Quality Systems Coordinator (Mexicali)
🏢 North American Production Sharing
📍 Mexicali