Medical Device R&D Quality Engineer

Location Tokyo
Job type Permanent
Salary 8,000,000 - 10,000,000 JPY
Reference 33103

【COMPANY OVERVIEW】

  • Global Biotechnology company focusing on innovative precision based cancer therapies

【JOB RESPONSIBILITIES】

  •  Communicate with overseas manufacturers to improve / develop the medical device components.

  •  Build strong relationship with external partners

【WHY YOU SHOULD APPLY】

  • You will be the pioneering person for this role in the company

  • Career development support (training and promotions)

  • Start up environment

  • Working with a diverse and motivated team with excellent work culture

【REQUIREMENTS】

  • 5+ years Knowledge of relevant Medical Device industry.

     

  • Experience of managing Medical Device class Ⅱ or Ⅲ

     

  • Knowledge of through the product planning, specification determination, design, and evaluation.

     

  • Experience in the manufacture for medical devices is plus

     

  • Understanding of relevant regulations and guidelines, e.g. ISO13485, ISO14971, IEC60601-1 and IEC60601-1-2.

     

  • Knowledge of QMS and / or ISO 13485, or sufficient knowledge of quality certification

     

  • Very good communication and problem solution skill among cross-functional team.

     

  • Ability to communicate reading, writing and speaking.

     

  • Bachelor's Degree in Engineering or related discipline

     

  • Strong Communication skill with external parties.