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Open nowPosted 1866 days ago

Japan medical device QMS 13485 auditor (relocation)

bsigroup220 open roles

Where
USA
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Your applicationOpen nowJapan medical device QMS 13485 auditor (relocation)bsigroup · USA

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. bsigroup postings stay open a median of 13 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 1866 days ago

bsigroup median: 13 days open

The posting

Great that you're thinking about a career with BSI!

当社は、マネジメントシステム審査登録、医療機器認証サービス、ISO規格を中心とした研修・トレーニング、規格関連情報や、リスク低減ツール、規格策定サービスの紹介など、幅広い分野にわたって付加価値を提供しているトータル・ソリューション・カンパニーです。 現在ではビジネスの領域を規格への適合性評価や教育・研修分野に広げ、180ヵ国以上でビジネスを展開し、世界中で81,000以上のお客様と取引をしております。 イギリス本社は1901年の設立以来、国家規格協会のパイオニアとして様々なISO規格を開発し、現在も世界でも歴史のある国家規格協会として、また独立した専門的ビジネスサービスを提供する機関として世界中に90のオフィスを構えています。

【業務内容】 ISO 13485 におけるQMS審査業務

【必須（MUST）】

能動または非能動医療機器審査員として以下の経験がある方

・大卒以上の学歴（理系） ・能動または非能動医療機器メーカーでの設計開発、製造などの実務経験 ・英語を使った実務経験

＊能動医療機器

電気系の学歴と職務経験（医療機器の設計や開発）が求められます。

＊非能動医療機器

電気系以外の学歴と職務経験（医療機器の設計や開発）が求められます。

特に『滅菌』の経験がある方は歓迎。

【歓迎（WANT）】

・品質マネジメントシステムに関する知識や経験 ・審査員コース合格者/ 審査員資格保持者 ・内部監査員経験

【求める人物像】 ・業務を遂行し、卓越したパフォーマンスへの努力を惜しまず、困難な課題も達成する ・人と積極的に関わり、模範を示してリードする ・ビジネスへの熱意を示し、他のスタッフに刺激を与える ・誠意を持ち、倫理マナーに沿って確実にビジネスを実行する ・商業的な焦点を持ち、顧客のニーズを理解し、付加価値を与える

＊審査員になるまでの過程においてはＢＳＩより必要なトレーニングを提供しています。

勤務地：本社（みなとみらい）

＊ISO13485 審査員は上長承認後に在宅勤務となります。

勤務時間：9：00～17：30（休憩60分）

休日休暇：土日祝祭日、有給休暇初年度最大14日（入社月によって異なります）、慶弔休暇など

待遇：通勤費、各種社会保険、

賞与：業績連動型、給与見直し（年1回）、企業型確定拠出年金（60歳未満の正社員対象）の適用となります。

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.

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