Job ID : 1069899 Date Updated : October 14th, 2020
Global Diagnostic Company

PMS Quality Specialist for IVD Company

Hiring Company 非公開
Location Tokyo - 23 Wards
Job Type Permanent Full-time
Salary 8 million yen ~ 10 million yen

Job Description

Company Profile:

International biomedical testing company.


The Post-market quality assurance specialist will be responsible for the following tasks (not comprehensive):


  1. To enter complaints from customers into global complaint handling database, evaluate the complaints and make investigation reports to the customers
  2. To prepare for field actions, management of progress of the field actions and report to Japanese health authorities
  3. To conduct trend analysis of complaints and feedback the result to the manufacturing plants (including overseas plants) and discuss countermeasures, corrective actions, etc.
  4. To maintain internal quality information database.
  5. To lead CAPA processes (Domestic)
  • As a general QA, establish SOPs to comply with JQMS, and play a SME role.


General Requirements

Minimum Experience Level Over 3 years
Career Level Mid Career
Minimum English Level Fluent
Minimum Japanese Level Native
Minimum Education Level Bachelor's Degree
Visa Status Permission to work in Japan required

Required Skills

  • Minimum 5 years' experience in Quality Assurance/Quality Control.
  • Business level Japanese (Frequent communication in Japanese by e-mail, teleconference, etc.)
  • Business level English (Frequent communication in English by e-mail, teleconference, etc.)


  • Bachelor's degree in an Electrical engineering, Mechanical engineering, Medical engineering or Pharmaceutical Sciences
  • Experience and/or knowledge of electrical medical devices
  • Experience and/or knowledge of In-vitro diagnostic reagents
  • Experience of Sokatsu, Hinseki or Anseki
  • Experience of Medical product design, Service

Job Location

  • Tokyo - 23 Wards

Work conditions

Job Type Permanent Full-time
Salary 8 million yen ~ 10 million yen
Work Hours 会社規定に準ずる

Hiring Company Information

Company Type International Company
Recruiter Company Information

PERSOL CAREER CO., LTD.(Bilingual Recruitment Solutions)

PMS Quality Specialist for IVD Company - 1069899

Company Description

バイリンガル・リクルートメント・ソリューションズ(BRS)は、パーソルキャリア株式会社のバイリンガル /マルチリンガル専門部署です。職種別のコンサルタントが、専門性と人脈を活かした丁寧なコンサルティングを通して、語学力を活かしたい転職希望者様と即戦力を求める日系/外資系企業をおつなぎします。

東京都 千代田区 紀尾井町4-1
ニューオータニ ガーデンコート18F

大阪府 大阪市北区 大深町3-1
グランフロント大阪タワーB 17F

Bilingual Recruitment Solutions (BRS) is a division of PERSOL CAREER CO., LTD. that focuses on connecting multilingual professionals with businesses across all industries in Japan. Those looking for a bilingual/multilingual career will find our position in the market to be unique; our consultants are able to provide tailored career counseling based on job specializations, while at the same time leveraging the extensive resources of PERSOL CAREER.

BRS Tokyo Office
18F New Otani Garden Court
4-1 Kioi-cho, Chiyoda-ku
Tokyo, Japan, 1020094

BRS Osaka Office
17F, Grand Front Osaka Tower B
3-1 Ofukacho, Osaka-shi Kita-ku
Osaka, Japan, 5300011