Japan medical device QMS 13485 auditor (relocation)
Apply NowCompany: The British Standards Institution (BSI)
Location: Des Moines, IA 50380
Description:
Great that you're thinking about a career with BSI!
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Medical Device 13485 Auditor in Japan /relocate to Japan(homebased)
We are looking for the candidate who is active searching this relocation opportunity in Japan.
As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.
In the first six months of being a Medical Device Auditor you'll:
In a typical week after being fully trained you'll:
To thrive in this career, you must:
We're enthusiastic to receive applications from those based in Japan/ relocate to Japan excited by this career opportunity.
#LI-VW
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
,,,ISO ,,,, .
,180,81,000.
1901,ISO,,90.
[]
ISO 13485 QMS
[(MUST)]
()
,
*
().
*
().
"".
[(WANT)]
/
[]
,,
,
,
,
,,
*I.
:()
*ISO13485 .
:9:00~17:30(60)
:,14(),
:,,
:,(1),(60).
Medical Device 13485 Auditor in Japan /relocate to Japan(homebased)
We are looking for the candidate who is active searching this relocation opportunity in Japan.
As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.
In the first six months of being a Medical Device Auditor you'll:
- Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)
- Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across EMEA and remotely from your home office.
In a typical week after being fully trained you'll:
- Conduct an audit on site or remotely
- Write up your reports and liaise with the planning team to manage your audit schedule.
- You'll also continue your development of MDR and be an advocate for the ISO 13485 EMEA Delivery Team.
To thrive in this career, you must:
- Have 4 years or more being directly accountable for the design or test or manufacture of different medical devices.
- Be degree educated with discipline relevant to Medical Devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar.
- Have at least 2 years' experience working in an environment with a Quality Management System established .
- Be able to speak and write fluently in the Japanese and English language.
- Be resilient and able to meet audit delivery by travelling frequently across the EMEA region as required
We're enthusiastic to receive applications from those based in Japan/ relocate to Japan excited by this career opportunity.
#LI-VW
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.