Descripción Review, advise and continually improve the quality management system (QMS) based on the requirements of ISO 9001 International Quality Management System Requirements and ISO 13485, FDA 21CFR part 820, Canadians and Japanese regulation MHLW Ministerial Ordinance No.
169. This includes developing the appropriate level of documentation (procedures, instructions, forms, etc.) to comply with the above mentioned standards.
Provides the strategic quality direction to the company; serves as a change agent to drives operational efficiencies and quality excellence.
Where required by the top management assist in the development and implementation of ISO 9001and 13485 based Quality Management System at Getinge s operations.
Participates in product quality planning activities and approve process validations to ensure the successful introduction of new products equipment and processes.
Support quality metrics and reporting methods establishment, gather appropriate data, and clearly communicates quality expectations and results throughout the organization.
Responsible for the document control system in the site.
Administer the NCR’s System
Serve as CAPA coordinator of the site and responsible for the timely completion of the CAPA process.
Comply and participate in Environmental, health & safety programs and support plant activities to enforce a safe and healthful work environment.
Requisitos 5 years in a formal supervisory role.
21 CFR 820
J Pal requirements Indispensable
ISCO Empleados de oficina, grupo 4