Jobs

Medical Device Auditor / Quality Engineer

Return to search Apply Now
Published:   2020/08/05

Type

Full time

Category

Medical Device

Salary

¥ 9,000,000 Yearly

Education

BS

Required language

English: Business advanced

Working hours

core time 11:00-15:00 (flex time0¥)

Reason for hiring

Catching up on the roles, getting more details 1.) Contract sent (35% on total package) - was forwarded to the legal department, will be back with it within one week 2.) Medial Auditor role* ideally 30-50's, younger or older (up to 55) ok, up to 9M, perm position, 6 months probation period English necessary for reports, internal communication and reading - business level at least, German Manager will test it technical degree and work experience with medical devices necessary trouble shooting, good communication with clients as they have to explain reports in detail and need to handle compaints always open position, want to hire 5 additionally, interviewed already 50 ppl, have yearly 10 hires for this team (Auditors and Project Engineers) Travel frequency within Japan probably half the month, rarely travels to Germany (HQ) or Asia Pacific Team: 51 ppl incl. Coordinator, Managers, Auditors & Project Engineers are 30-38 ppl, Sales 2 Direct reporting line to jap. Medical Device Manager, above him is a German manager Interviews (one needs to be in the office) 1, HR & Japanese Manager, 2. Auditor and HR (to check knowledge), 3. Interview is optional, if there are any open questions Challenge: always open, medical device team the only one where there are hires at the moment during the interview, they will decide if the candidate is more a fit to Medical Auditor role or Project Engineer (more technical) need a decent level of English as well as a strong understanding of medical devices open for foreigners if fluent Japanese, training will be OJT by Japan team

Location

Other

Description

Position: Medical Device Auditor
Salary range: 8,000,000 - 10,000,000
 
Well known European Company that has over 400 staff here and have been in Japan for over 50 years. 

As an auditor, you will provide auditing and certificate services for active medical devices following ISO13485, 9001, EC, MDR/IVDR, and Pharmaceuticals and Medical Devices Law by closely communicating with the auditing team and clients.

Requirements:

  • Bachelor’s degree in electrical engineering preferred
  • Business - fluent level in English
  • Work Experience: Over 4 years of work experience in medical/ diagnostics field, especially in imaging a big plus

Benefits:

  • Social Insurance including health insurance, pension, employment insurance
  •  15 days of paid holidays for the first year (prorated)
  •  Flex time (Core time 11:00-15:00)
  •  Selective 401K
  •  One time allowance for continuous work at certain stage
  •  Sick leave, child sick leave, nursing care leave, condolence leave
  •  Maternity leave, reduction of working hours for child care
  •  Financial support for external education programs
  •  Counseling services
  •  Office massage
  •  Free coffee/tea

 

Benefits

Social Insurance including health insurance, pension, employment insurance  15 days of paid holidays for the first year (prorated)  Flex time (Core time 11:00-15:00)  Selective 401K  One time allowance for continuous work at certain stage  Sick leave, child sick leave, nursing care leave, condolence leave  Maternity leave, reduction of working hours for child care  Financial support for external education programs  Counseling services  Office massage  Free coffee/tea