- Developing and maintaining Quality Management System (as a QMR) in accordance with the International Quality Assurance Standard (ISO9001 *and ISO13485*).
- Ensuring that the processes needed for all related Quality Management System are established, implemented and maintained.
- Developing and maintaining a documented which related to Quality Management System use throughout the company which ensures customer satisfaction whilst achieving world class performance and continuous improvement.
- Effective co-ordination of activities with respect to products intended for use in potentially explosive atmospheres.

Liaison with responsible CB, ExCB or NB related to overall of certificate and quality system document.
Inform to customer and responsible ExCB or NB in case of any unsafe or NC products that have been shipped to customer (Only for ATEX product).
- Monitoring and auditing process to evaluate an effectiveness of the documented quality system and reporting the performance of the Quality Management System and any need for improvement top management.




- Ensuring the promotion of quality awareness, customer requirements and *regulation* throughout the organization.
- Toprepare of any revise / change or new regulatory / requirements concerned to medical device for review in management review meeting.
- Developing and maintaining measuring/testing equipment effectiveness & economically
- Overseeing in quality control of Supplier Materials/Products also support the Purchasing for
- Supplier Quality Development activities.
- Collecting and reporting monthly on Key Performance Indicators, with a view to identifying
- Trends and opportunities for improvement.
- Reviewing to ensure the effectiveness of corrective action / preventive action which related to supplier quality issued, internal quality issued, Customer complaint, Internal Audit and External Audit.
- Developing and maintaining environmental occupational health & safety management system (as a

E&SMR;) according to

📌 Quality & EHS Manager (Guadalajara)
🏢 GPV Mexico
📍 Guadalajara