Are you a Tochigi Plant QM Dept. Q&V(Qualification & Validation) Representative passionate about ensuring Q&V documentations / activities? If so, this opportunity could be for you! Join us in Tochigi at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!

As a Tochigi Plant QM Dept. Q&V(Qualification & Validation) Representative at B. Braun you will play a vital role in managing and improving the quality of purchased materials in close collaboration with external suppliers. You will be an integral part of Tochigi’s site QM with functional reporting line to the global Quality Control organization.

Your key responsibilities:            

The following tasks are generally conducted by a Q&V(Qualification & Validation) Representative. Collaboration with the global QC team is essential (English communication support from a QM Senior Manager is available).

• Application of global SOPs concerning Q&V at site
• Local training of Q&V SOPs (Q&V team leader and project leaders)
• Implementation of global qualification requirements in the local qualification matrix
• Review of global SOPs with respect to national law and regulations
• Change management / CAPA at site that concern Q&V activities
• Creation and monitoring of local VMP and VPrg
• Approval of Q&V team leader according to project with respect to qualification matrix
• Creation and/or approval of Q&V documents according to chapter 5.10
• Reporting of results of Q&V activities to QA/QM especially in case of failure
• Reporting Q&V activities to Q&V Global and site management
• Feedback to Q&V Manager Global in case of systematic Q&V issues

The following tasks are currently conducted by the global supporting team or not applicable at Tochigi Plant. Necessary tasks are expected to be established by a Q&V(Qualification & Validation) Representative.

• A Q&V Representative Sterilization (production site)
• Establishment of a SPC (Statistic Process Control)

What you will bring to the team:

• Graduate engineer, scientist, microbiologist or comparable training (Bachelor's / Master's Degree) or with extensive working experience
• Additional training: QM specialist and/or Quality auditor (Knowledge of ISO 9001, ISO 13485, MDSAP, US FDA etc.)
• Experience in professional and disciplinary ensuring Q&V documentations / activities advanced project management knowledge
• English – Business-level proficiency in reading and writing required; ability to communicate verbally in English is preferred.
• Mind to lead the project proactively to achive goals
• You take full ownership of your responsibilities and deliver results in your area of expertise
• You are skilled negotiator and professional in local (international communications are preferred)

What sets B. Braun apart?

The Tochigi Plant of B. Braun Aesculap Japan is a manufacturing facility that is integral to B. Braun Group’s delivery of injection needles. We assemble and produce millions of anaesthetic needles per month. As well as being used by anaesthesiologists here in Japan our specially manufactured needs designed to inject into the spine are also exported to our affiliated companies in Germany, Malaysia, and the United States. This means that by joining us you instantly begin contributing to our shared vision – to protect and improve the health of people around the world.

At B. Braun, we foster a culture of trust and collaboration, ensuring compliance with the highest ethical standards. Apply now to join a team that truly makes a difference!

What can we offer you? To be removed by Recruiter as required

• Bonus twice a year (for a total of 4 months in the previous year)
• Performance bonus
• Transportation expenses
• Complete with social insurance
• 123 days off per year and annual paid leave
• Retirement allowance system (3 years or more of service)
• Employee cafeteria
• Benefit station subscription
• Influenza vaccination assistance
• Shortened working hours for childcare is available (for children up to the sixth grade of elementary school)
• Babysitting system available

What’s next?

Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. We ask you to conduct two interviews, one in person and one remotely. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to

ビー・ブラウンエースクラップ株式会社の情報はこちら
Website：https://www.bbraun.jp/ja.html
YouTube：https://www.youtube.com/channel/UCM0_NCoY4pif0mPNU85MCPA
LinkedIn：https://www.linkedin.com/company/bbraun-group/

お問合せ窓口    
人事総務本部　採用担当
E-mail: recruiting.jp@bbraun.com
採用ページ：https://www.bbraun.jp/ja/career/recruiting-japan.html