Quality Engineering Manager

Gaishi to set up new production in Japan

7 - 10 million yen Tokyo Medical Device Product Engineering

Job details

Company overview: Our client is a clinical-stage biotechnology company.
Responsibilities: Contribute to cross-functional project(s) as engineering expert.
Communicate with external manufactures to improve / develop the medical devices.
Build strong relationship with external partners.
Compliance with Quality Policy and regulations
Requirements: 3 + years Knowledge of relevant Medical Device industry.
Knowledge of design control and risk management for Medical Device.
Experience of through the product lifecycle of Medical Device including pre-market and post-market.
Experience in the manufacture for medical devices.
Experience in the creation of Quality Management System documents.
Expertise in the mechanical design, polymer material and manufacturing engineering for medical devices are plus.
Understanding of relevant regulations and guidelines, e.g. ISO13485, ISO9001, ISO14971 FDA 21 CFR Part 820.
Very good communication and problem solution skill among global cross-functional team.
Strong Communication skill with external parties.
Business level of English.
Salary: 7 - 10 million yen
Location: Tokyo

BRS Consultant
Linh Do
Medical Device

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