Quality Systems Senior Specialist||品質管理シニアスペシャリスト

Company overview: designs, manufactures, and distributes medical devices used in infusion therapy. Provides infusion therapy products, implantable access systems, dialysis and infusion catheters, needles, and insulin delivery systems. The company also provides drug delivery technology solutions for companies and organizations involved in drug discovery and therapy innovation. It offers solutions in the areas of airway management, pain management, needle protection, arterial blood sampling, temperature management, critical care monitoring, hospital and ambulatory infusion, and vascular access. 

Responsibilities:
Maintain Divisional Quality Management System in accordance with global requirements
Responsibility of CAPA specialists and training specialist
Support Line Manager in planning, arranging and conducting periodical management review under QMS
Ensure high regulatory compliance with PMDA and QMS ordinance in accordance with Tokyo HQ
Plan and conduct QMS and GVP education for emloyees including new hires.
Conduct internal quality audit as a certified member
Support document control activity
Support regulatory activities
Keep good communication with GQR and each function within SMJ

This position is required to assure compliance of Company operation to all applicable laws, regulations and standards, good business practices and company document procedures (including knowledge of all standard government occuptional health and environmental regulations)

Technical Knowledge/Skills:
Bachelor degree in Science, Chemical or Engineering area
5 years experience in Medical Devices or equivalent
Knowledge of Japanese PMD Act. and related laws
Experience in the quality assurance field required
Business level English (verbal and written communication)
Superior communication skills

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