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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
Good command for English.
