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- Tasks: Conduct audits and reviews to ensure medical device compliance and safety.
- Company: Join BSI, a leader in business improvement and standards with a global impact.
- Benefits: Remote work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in patient safety and product innovation.
- Qualifications: 4+ years in microbiology or sterilization engineering; degree in related field required.
- Other info: Work in a diverse, inclusive environment with a focus on positive change.
The predicted salary is between 36000 - 60000 £ per year.
We exist to create positive change for people and the planet. Join us and make a difference too!
Job title: Technical Specialist and Scheme Manager (Microbiology)-relocation acceptable
Location: Japan/South Korea (remote)
This role required to work in Japan or South Korea
Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change?
BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. In this role you will have the opportunity to apply your sterile medical device experience to impact patient safety and help determine which new products go to market.
Technical Specialist Responsibilities:
- Responsible for planning, reporting and performing of audits of clients’ management systems ensuring compliance with regulatory and voluntary requirements.
- Conduct comprehensive in-depth medical device reviews (including sterilization validation).
- Make recommendation whether to issue a certificate, based on objective evidence that the device is safe and effective.
The Technical Specialist – Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria.
Education/Qualifications:
- A minimum of four (4) years’ experience working as a microbiologist and/or sterilization engineer for asterile medical device manufacturer
- Bachelor’s degree (or higher) in Microbiology, Biology or related scientific degree
- Familiar with Gamma and EO sterilization
- Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR)
- Quality management experience including significant participation in third party quality audits
- If you apply the role in Japan, then Native Japanese speaking required.
- If you apply the role in South Korea then Native Korean speaking required.
About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors – including automotive, aerospace, built environment, food and retail, and healthcare – BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between – to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
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Sterilization validation expert/R&D Microbiology(remote in Japan) employer: BSI
Contact Detail:
BSI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterilization validation expert/R&D Microbiology(remote in Japan)
✨Tip Number 1
Network like a pro! Reach out to your connections in the microbiology and sterilization fields. Attend industry events or webinars, and don’t be shy about asking for introductions. We all know someone who knows someone, so leverage that!
✨Tip Number 2
Prepare for interviews by researching the company and its values. Understand their mission to create positive change for people and the planet. When you align your answers with their goals, it shows you’re not just looking for any job, but you genuinely want to contribute.
✨Tip Number 3
Practice your communication skills! As a Technical Specialist, you’ll need to convey complex information clearly. Grab a friend or family member and do mock interviews. The more comfortable you are, the better you’ll perform when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us. So, get your application in and let’s make a difference together!
We think you need these skills to ace Sterilization validation expert/R&D Microbiology(remote in Japan)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Technical Specialist in Microbiology. Highlight your relevant experience in microbiology and sterilization, and don’t forget to mention your familiarity with ISO 13485. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your skills can make a difference at BSI. Be sure to connect your experience with our mission of creating positive change for people and the planet.
Showcase Your Communication Skills: As a Technical Specialist, clear communication is key. In your application, demonstrate your ability to convey complex information simply and effectively. This will show us that you can confidently interact with clients and make those tough decisions we talked about.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at BSI
✨Know Your Stuff
Make sure you brush up on your knowledge of ISO 13485 and the specifics of sterilization methods like Gamma and EO. Being able to discuss these topics confidently will show that you're not just familiar with the theory, but you can apply it practically.
✨Showcase Your Experience
Prepare to share specific examples from your past roles as a microbiologist or sterilization engineer. Highlight any audits you've conducted or certifications you've recommended, as this will demonstrate your hands-on experience and decision-making skills.
✨Practice Clear Communication
Since this role involves communicating complex information to clients, practice explaining technical concepts in simple terms. This will help you convey your ideas clearly during the interview and show that you can engage effectively with clients.
✨Cultural Fit Matters
Research BSI's core values of Client-Centricity, Agility, and Collaboration. Think about how your personal values align with theirs and be ready to discuss this in the interview. Showing that you understand and resonate with their mission can set you apart from other candidates.
