- 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 sterilisation validation).
- Make recommendation whether to issue a certificate, based on objective evidence that the device is safe and effective.
- A minimum of four (4) years' experience working as a microbiologist and/or sterilisation engineer for a sterile medical device manufacturer (REQUIRED)
- Bachelor's degree (or higher) in Microbiology, Biology or related scientific degree (REQUIRED)
- Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR)
- Ability to travel 40% to 60% via car and plane.
- ISO 13485 Lead Auditor experience desirable.
- Quality management experience including significant participation in third party quality audits
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Medical Device Sterilisation Expert - United Kingdom - BSI Group
Description
Medical Device Sterilisation Expert page is loaded
Medical Device Sterilisation Expert
Apply locations United Kingdom Netherlands Ireland Italy France posted on Posted 3 Days Ago job requisition id JRGreat that you're thinking about a career with BSI
About the role:
Are you a Microbiologist, Sterilisation Engineer, or Quality Manager looking for an interesting career change? Then this could be the opportunity for you
Here at BSI we hire qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilisation, packaging and microbiological testing outlined under ISO 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.
This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits.
This is an EMEA home-based position with 40-60% travel to client sites (once COVID-19 restrictions lift) so candidates must be located near a major airport.
Technical Specialist Responsibilities:
Education/Qualifications:
What we offer:
We offer a competitive salary and benefits package dependent on the country, more details can be provided at discussion stage.
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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 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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locations 16 Locations time type Full time posted on Posted 30+ Days AgoAbout Us
BSI continues to support our people and clients to make a difference during this challenging time. Our focus on Innovation in the way we support the COVID 19 effort, continue to deliver to clients and adapt through agile working methodologies are helping us navigate these unique times. We are still recruiting especially in areas that are Client facing and Business Development , and you can find vacancies advertised on Workday – Career – Find Jobs. We are conducting Virtual Interviews and Inductions, it's amazing how positively people are embracing new ways of working and staying connected. Stay safe.
Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business. BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.
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