Abbott Sr QA Specialist in Ansan,
· Develops/maintains the Quality Management System and practices for importing, field refurbishing and distribution operations within the context of corporate and divisional quality policies and governmental regulations.
· Formulate short-term and long-range quality objectives, plans and programs, working closely with divisional quality organizations.
· Manage the quality inspection and test activities to include incoming inspection on spare parts and packaging materials, and finished goods and imported products release to ensure the quality conformances
· Prepare and maintain the Korean labels and package inserts for IVD products.
· Manage the auditing and approval of Distributors to ensure maintenance of ADD Global quality standards and specifications and governmental regulations.
· Participate in the analysis of product performance problems and product nonconformance in conjunction with divisional quality.
· Prepare, implement and maintain appropriate quality, importing, and warehousing documents, records and files.
· Manage the local compliance with regard to Field Action and Quality Hold for IVD products with communicating with Global Quality groups.
· Monitor and manage all mandatory training activities for employees within QMS as per global and governmental requirements.
· Perform other activities assigned and/or instructed by direct supervisor.
Assist the RA team for the development, establishment and implementation of all aspects of the quality assurance and quality control for country to ensure that products manufactured and imported meet standards and specifications required by Abbott policies and governmental requirements where applicable.
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