Quality & EHS Manager

Gpv Group; Región Centro; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Gpv Group seeks a seasoned Quality Management professional to develop and maintain our QMS in line with ISO 9001 and ISO 13485. You will coordinate activities for products used in potentially explosive atmospheres and liaise with CB/ExCB/NB for certificates and documentation.

You will monitor effectiveness, report KPIs, and drive CAPA related to supplier quality, internal audits, and customer issues, while advancing environmental and safety programs per ISO 14001 and OHSAS18001.

Formación

• Bachelor’s degree or higher in Engineering or related field.
• 10 years of experience with at least 5 in management.
• Knowledge of ISO 14001, ISO 9001 and ISO 13485 standards.
• Strong leadership, teamwork, and analytical thinking.

Responsabilidades

• Developing and maintaining the Quality Management System (QMS) per ISO9001/13485.
• Co-ordinate activities related to products used in potentially explosive atmospheres.
• Liaise with CB/ExCB/NB for certificates and QMS documents.
• Monitor, audit, and report KPI performance of the QMS.
• Drive corrective and preventive actions for supplier quality and internal issues.
• Maintain environmental, occupational health & safety management (ISO 14001, OHSAS18001).
• Prepare regulatory/revision changes for management review.

Conocimientos

Quality management

Regulatory compliance

Auditing

Leadership

Supplier quality

Environmental health & safety

Educación

Bachelor’s degree in Engineering or related field

Descripción del empleo

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.

To prepare 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 International Environment Management System (ISO 14001: 2015), ISO 9001: 2015, ISO 13485: 2016 and Occupational Health & Safety Management System (OHSAS18001).

Bachelor’s degree or above in Engineering or related field.

Experience 10 years and 5 years in management level.

ISO 140001 knowledge

Strong leadership and team player, good attitude, logic thinking