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 ...
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 ...
The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...
The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...
Overview This Sterilization Medical Device Auditor position is an excellent opportunity for recent retirees or consultants that have Sterilization experience in Ethylene Oxide or Radiation(Gamma ...
Overview This Sterilization Medical Device Auditor position is an excellent opportunity for recent retirees or consultants that have Sterilization experience in Ethylene Oxide or Radiation(Gamma ...
The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...
The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...
The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...
The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...
Medical Device Auditors - Full-time - Travel based Auditor. Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for a Medical Device ...
Medical Device Auditors - Full-time - Travel based Auditor. Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for a Medical Device ...
Medical Device QMS Auditor
Reston, VA ยท On-site
$98K - $123K/yr
Medical Device QMS Auditor Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH. BSI (British Standards Institution) is the global business standards ...
Medical Device QMS Auditor
Reston, VA ยท On-site
$98K - $123K/yr
Medical Device QMS Auditor Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH. BSI (British Standards Institution) is the global business standards ...
Quality Auditor - Pharmaceutical/Medical Device
Ellsworth, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Ellsworth, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Algoma, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Algoma, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Duluth, MN ยท On-site
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Duluth, MN ยท On-site
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Shakopee, MN ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Shakopee, MN ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Des Moines, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Des Moines, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Monticello, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Monticello, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Franklin, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Franklin, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Chicago, IL ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Chicago, IL ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
East Grand Forks, MN ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
East Grand Forks, MN ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Blaine, MN ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Blaine, MN ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Milwaukee, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Milwaukee, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Manitowoc, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Manitowoc, WI ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Cedar Rapids, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Quality Auditor - Pharmaceutical/Medical Device
Cedar Rapids, IA ยท Remote
$1K/day
... medical device, and/or biologics industries * Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820 * Strong ...
Medical Device Auditor information
See salary details
$13.94 - $15.30
6% of jobs
$15.30 - $16.65
4% of jobs
$17.48 is the 25th percentile. Wages below this are outliers.
$16.65 - $18.01
23% of jobs
The median wage is $19.20 / hr.
$18.01 - $19.36
18% of jobs
$19.36 - $20.72
12% of jobs
$20.72 - $22.07
1% of jobs
$22.07 - $23.43
1% of jobs
$23.43 - $24.78
3% of jobs
$24.78 - $26.14
5% of jobs
$26.25 is the 75th percentile. Wages above this are outliers.
$26.14 - $27.49
6% of jobs
$27.49 - $28.85
19% of jobs
$13
$21
$28
How much do medical device auditor jobs pay per hour?
As of Jun 9, 2026, the average hourly pay for medical device auditor in the United States is $21.62, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $27.40 per hour, depending on experience, location, and employer.
What are the key skills and qualifications needed to thrive in the Medical Device Auditor position, and why are they important?
To excel as a Medical Device Auditor, you need a solid background in quality management systems, regulatory compliance, and a relevant science or engineering degree. Familiarity with ISO 13485, FDA regulations, and audit management software is highly valued, as are certifications such as Lead Auditor or RABQSA/IRCA credentials. Strong analytical skills, attention to detail, and the ability to communicate findings diplomatically are key soft skills for the position. These abilities ensure audits are thorough, regulatory requirements are met, and issues are effectively communicated to drive continuous improvement in medical device manufacturing.
What is a Medical Device Auditor job?
A Medical Device Auditor is responsible for evaluating medical device manufacturers to ensure compliance with regulatory standards such as ISO 13485, FDA regulations, and EU MDR. They conduct audits, review documentation, and assess quality management systems to verify that products meet safety and performance requirements. Their role helps ensure that medical devices are safe for patient use and meet industry standards. Auditors may work independently or for regulatory bodies, certification organizations, or manufacturers. Strong knowledge of regulatory frameworks and auditing techniques is essential for this role.
What does a typical workweek look like for a Medical Device Auditor?
A typical workweek for a Medical Device Auditor often involves a combination of preparing audit materials, conducting on-site or remote audits, reviewing technical documentation, and writing comprehensive audit reports. Depending on the employer, you may travel to manufacturing sites or interact virtually with client teams to assess compliance with regulatory standards. Collaboration with quality assurance teams, engineers, and regulatory affairs professionals is common, as you help organizations identify and address potential gaps in their quality systems. This role offers a dynamic environment and the opportunity to stay updated with evolving industry regulations, making each week varied and engaging.
More about Medical Device Auditor jobs
What cities are hiring for Medical Device Auditor jobs? Cities with the most Medical Device Auditor job openings:
What are the most commonly searched types of Medical Device Auditor jobs? The most popular types of Medical Device Auditor jobs are:
What states have the most Medical Device Auditor jobs? States with the most job openings for Medical Device Auditor jobs include:
What job categories do people searching Medical Device Auditor jobs look for? The top searched job categories for Medical Device Auditor jobs are:
Japan medical device QMS 13485 auditor (relocation)
The British Standards Institution (BSI)Reston, VA โข On-site
Full-time
Posted 18 days ago
Job description
Great that you're thinking about a career with BSI!
ๅฝ็คพใฏ,ใใใธใกใณใใทในใใ ๅฏฉๆป็ป้ฒ,ๅป็ๆฉๅจ่ช่จผใตใผใใน,ISO่ฆๆ ผใไธญๅฟใจใใ็ ไฟฎโข ใใฌใผใใณใฐ,่ฆๆ ผ้ข้ฃๆ ๅ ฑใ,ใชในใฏไฝๆธใใผใซ,่ฆๆ ผ็ญๅฎใตใผใในใฎ็ดนไปใชใฉ,ๅน ๅบใๅ้ใซใใใฃใฆไปๅ ไพกๅคใๆไพใใฆใใใใผใฟใซโข ใฝใชใฅใผใทใงใณโข ใซใณใใใผใงใ.
็พๅจใงใฏใใธใในใฎ้ ๅใ่ฆๆ ผใธใฎ้ฉๅๆง่ฉไพกใๆ่ฒโข ็ ไฟฎๅ้ใซๅบใ,180ใตๅฝไปฅไธใงใใธใในใๅฑ้ใ,ไธ็ไธญใง81,000ไปฅไธใฎใๅฎขๆงใจๅๅผใใใฆใใใพใ.
ใคใฎใชในๆฌ็คพใฏ1901ๅนดใฎ่จญ็ซไปฅๆฅ,ๅฝๅฎถ่ฆๆ ผๅไผใฎใใคใชใใขใจใใฆๆงใ ใชISO่ฆๆ ผใ้็บใ,็พๅจใไธ็ใงใๆญดๅฒใฎใใๅฝๅฎถ่ฆๆ ผๅไผใจใใฆ,ใพใ็ฌ็ซใใๅฐ้็ใใธใในใตใผใในใๆไพใใๆฉ้ขใจใใฆไธ็ไธญใซ90ใฎใชใใฃในใๆงใใฆใใพใ.
[ๆฅญๅๅ ๅฎน]
ISO 13485 ใซใใใQMSๅฏฉๆปๆฅญๅ
[ๅฟ ้ (MUST)]
่ฝๅใพใใฏ้่ฝๅๅป็ๆฉๅจๅฏฉๆปๅกใจใใฆไปฅไธใฎ็ต้จใใใๆน
โข ๅคงๅไปฅไธใฎๅญฆๆญด(็็ณป)
โข ่ฝๅใพใใฏ้่ฝๅๅป็ๆฉๅจใกใผใซใผใงใฎ่จญ่จ้็บ,่ฃฝ้ ใชใฉใฎๅฎๅ็ต้จ
โข ่ฑ่ชใไฝฟใฃใๅฎๅ็ต้จ
*่ฝๅๅป็ๆฉๅจ
้ปๆฐ็ณปใฎๅญฆๆญดใจ่ทๅ็ต้จ(ๅป็ๆฉๅจใฎ่จญ่จใ้็บ)ใๆฑใใใใพใ.
*้่ฝๅๅป็ๆฉๅจ
้ปๆฐ็ณปไปฅๅคใฎๅญฆๆญดใจ่ทๅ็ต้จ(ๅป็ๆฉๅจใฎ่จญ่จใ้็บ)ใๆฑใใใใพใ.
็นใซ"ๆป ่"ใฎ็ต้จใใใๆนใฏๆญ่ฟ.
[ๆญ่ฟ(WANT)]
โข ๅ่ณชใใใธใกใณใใทในใใ ใซ้ขใใ็ฅ่ญใ็ต้จ
โข ๅฏฉๆปๅกใณใผในๅๆ ผ่ / ๅฏฉๆปๅก่ณๆ ผไฟๆ่
โข ๅ ้จ็ฃๆปๅก็ต้จ
[ๆฑใใไบบ็ฉๅ]
โข ๆฅญๅใ้่กใ,ๅ่ถใใใใใฉใผใใณในใธใฎๅชๅใๆใใพใ,ๅฐ้ฃใช่ชฒ้กใ้ๆใใ
โข ไบบใจ็ฉๆฅต็ใซ้ขใใ,ๆจก็ฏใ็คบใใฆใชใผใใใ
โข ใใธใในใธใฎ็ฑๆใ็คบใ,ไปใฎในใฟใใใซๅบๆฟใไธใใ
โข ่ช ๆใๆใก,ๅซ็ใใใผใซๆฒฟใฃใฆ็ขบๅฎใซใใธใในใๅฎ่กใใ
โข ๅๆฅญ็ใช็ฆ็นใๆใก,้กงๅฎขใฎใใผใบใ็่งฃใ,ไปๅ ไพกๅคใไธใใ
*ๅฏฉๆปๅกใซใชใใพใงใฎ้็จใซใใใฆใฏBSIใใๅฟ ่ฆใชใใฌใผใใณใฐใๆไพใใฆใใพใ.
ๅคๅๅฐ:ๆฌ็คพ(ใฟใชใจใฟใใ)
*ISO13485 ๅฏฉๆปๅกใฏไธ้ทๆฟ่ชๅพใซๅจๅฎ ๅคๅใจใชใใพใ.
ๅคๅๆ้:9:00~17:30(ไผๆฉ60ๅ)
ไผๆฅไผๆ:ๅๆฅ็ฅ็ฅญๆฅ,ๆ็ตฆไผๆๅๅนดๅบฆๆๅคง14ๆฅ(ๅ ฅ็คพๆใซใใฃใฆ็ฐใชใใพใ),ๆ ถๅผไผๆใชใฉ
ๅพ ้:้ๅค่ฒป,ๅ็จฎ็คพไผไฟ้บ,
่ณไธ:ๆฅญ็ธพ้ฃๅๅ,็ตฆไธ่ฆ็ดใ(ๅนด1ๅ),ไผๆฅญๅ็ขบๅฎๆ ๅบๅนด้(60ๆญณๆชๆบใฎๆญฃ็คพๅกๅฏพ่ฑก)ใฎ้ฉ็จใจใชใใพใ.
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.
ๅฝ็คพใฏ,ใใใธใกใณใใทในใใ ๅฏฉๆป็ป้ฒ,ๅป็ๆฉๅจ่ช่จผใตใผใใน,ISO่ฆๆ ผใไธญๅฟใจใใ็ ไฟฎโข ใใฌใผใใณใฐ,่ฆๆ ผ้ข้ฃๆ ๅ ฑใ,ใชในใฏไฝๆธใใผใซ,่ฆๆ ผ็ญๅฎใตใผใในใฎ็ดนไปใชใฉ,ๅน ๅบใๅ้ใซใใใฃใฆไปๅ ไพกๅคใๆไพใใฆใใใใผใฟใซโข ใฝใชใฅใผใทใงใณโข ใซใณใใใผใงใ.
็พๅจใงใฏใใธใในใฎ้ ๅใ่ฆๆ ผใธใฎ้ฉๅๆง่ฉไพกใๆ่ฒโข ็ ไฟฎๅ้ใซๅบใ,180ใตๅฝไปฅไธใงใใธใในใๅฑ้ใ,ไธ็ไธญใง81,000ไปฅไธใฎใๅฎขๆงใจๅๅผใใใฆใใใพใ.
ใคใฎใชในๆฌ็คพใฏ1901ๅนดใฎ่จญ็ซไปฅๆฅ,ๅฝๅฎถ่ฆๆ ผๅไผใฎใใคใชใใขใจใใฆๆงใ ใชISO่ฆๆ ผใ้็บใ,็พๅจใไธ็ใงใๆญดๅฒใฎใใๅฝๅฎถ่ฆๆ ผๅไผใจใใฆ,ใพใ็ฌ็ซใใๅฐ้็ใใธใในใตใผใในใๆไพใใๆฉ้ขใจใใฆไธ็ไธญใซ90ใฎใชใใฃในใๆงใใฆใใพใ.
[ๆฅญๅๅ ๅฎน]
ISO 13485 ใซใใใQMSๅฏฉๆปๆฅญๅ
[ๅฟ ้ (MUST)]
่ฝๅใพใใฏ้่ฝๅๅป็ๆฉๅจๅฏฉๆปๅกใจใใฆไปฅไธใฎ็ต้จใใใๆน
โข ๅคงๅไปฅไธใฎๅญฆๆญด(็็ณป)
โข ่ฝๅใพใใฏ้่ฝๅๅป็ๆฉๅจใกใผใซใผใงใฎ่จญ่จ้็บ,่ฃฝ้ ใชใฉใฎๅฎๅ็ต้จ
โข ่ฑ่ชใไฝฟใฃใๅฎๅ็ต้จ
*่ฝๅๅป็ๆฉๅจ
้ปๆฐ็ณปใฎๅญฆๆญดใจ่ทๅ็ต้จ(ๅป็ๆฉๅจใฎ่จญ่จใ้็บ)ใๆฑใใใใพใ.
*้่ฝๅๅป็ๆฉๅจ
้ปๆฐ็ณปไปฅๅคใฎๅญฆๆญดใจ่ทๅ็ต้จ(ๅป็ๆฉๅจใฎ่จญ่จใ้็บ)ใๆฑใใใใพใ.
็นใซ"ๆป ่"ใฎ็ต้จใใใๆนใฏๆญ่ฟ.
[ๆญ่ฟ(WANT)]
โข ๅ่ณชใใใธใกใณใใทในใใ ใซ้ขใใ็ฅ่ญใ็ต้จ
โข ๅฏฉๆปๅกใณใผในๅๆ ผ่ / ๅฏฉๆปๅก่ณๆ ผไฟๆ่
โข ๅ ้จ็ฃๆปๅก็ต้จ
[ๆฑใใไบบ็ฉๅ]
โข ๆฅญๅใ้่กใ,ๅ่ถใใใใใฉใผใใณในใธใฎๅชๅใๆใใพใ,ๅฐ้ฃใช่ชฒ้กใ้ๆใใ
โข ไบบใจ็ฉๆฅต็ใซ้ขใใ,ๆจก็ฏใ็คบใใฆใชใผใใใ
โข ใใธใในใธใฎ็ฑๆใ็คบใ,ไปใฎในใฟใใใซๅบๆฟใไธใใ
โข ่ช ๆใๆใก,ๅซ็ใใใผใซๆฒฟใฃใฆ็ขบๅฎใซใใธใในใๅฎ่กใใ
โข ๅๆฅญ็ใช็ฆ็นใๆใก,้กงๅฎขใฎใใผใบใ็่งฃใ,ไปๅ ไพกๅคใไธใใ
*ๅฏฉๆปๅกใซใชใใพใงใฎ้็จใซใใใฆใฏBSIใใๅฟ ่ฆใชใใฌใผใใณใฐใๆไพใใฆใใพใ.
ๅคๅๅฐ:ๆฌ็คพ(ใฟใชใจใฟใใ)
*ISO13485 ๅฏฉๆปๅกใฏไธ้ทๆฟ่ชๅพใซๅจๅฎ ๅคๅใจใชใใพใ.
ๅคๅๆ้:9:00~17:30(ไผๆฉ60ๅ)
ไผๆฅไผๆ:ๅๆฅ็ฅ็ฅญๆฅ,ๆ็ตฆไผๆๅๅนดๅบฆๆๅคง14ๆฅ(ๅ ฅ็คพๆใซใใฃใฆ็ฐใชใใพใ),ๆ ถๅผไผๆใชใฉ
ๅพ ้:้ๅค่ฒป,ๅ็จฎ็คพไผไฟ้บ,
่ณไธ:ๆฅญ็ธพ้ฃๅๅ,็ตฆไธ่ฆ็ดใ(ๅนด1ๅ),ไผๆฅญๅ็ขบๅฎๆ ๅบๅนด้(60ๆญณๆชๆบใฎๆญฃ็คพๅกๅฏพ่ฑก)ใฎ้ฉ็จใจใชใใพใ.
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.