US Oncology Diagnostics Company || ゲノム ベンチャー, (責任技術者)

Manufacture Engineer (Sekinin Gijutsusha) (Laboratory Control)
 Build and manage processes related to design and manufacturing.
 Guidance and other necessary technical support
 Work closely with Quality Manager, you will responsible for the partial verification and management of design part with domestic and overseas vendors and US HQ regarding ISO13485
 Determine the shipment of products on behalf of the quality manager

Quality Control
 Work closely with quality manager and responsible for maintaining and configuration of QMS and ISO13485, in accordance with change control processes
 Collaborate with the Tokyo Metropolitan Government, related regulatory authorities and US HQ and maintain and manage business.
 Supports the company's compliance activities with such as ISO, CAP, and applicable requirements.

Essential skill and abilities

 3+ years experience of Quality Assurance or Quality Control or GVP in the pharmaceutical/medical device industry
 Meet requirement of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices Article 114-53, Paragraph 1 医薬品慰労機器等法施工規則第114条53項第3項 (actual role is under Article 114, 53, Paragraph 3)
 Business English (verbal and written)

Qualifications
 Effective verbal and written communication skills
 understand start-up environment
 Self-starter and highly motivated
 Ability to work effectively in a team environment and build strong working relationships
 experience of ISO13485、ISO15189、ISO14971、CAP（College of American Pathologists）and Life Cycle Assessment experience is plus
 Oversea Business trip experience is plus
 Regulatory submission experience is plus
 Experience of Start-up Business is plus
 Experience of start and manage a new warehouse is plus
 Experience of Quality Assurance or Quality Control at the manufacturing is big plus

Work Environment:
• Travel is estimated to be approximately 35%.
• Must be physically able to handle extensive travel in vehicle, plane, or other modes of public transport.