Technical Specialist - Microbiology
Company: Environmental & Occupational
Posted on: November 24, 2022
Great that you're thinking about a career with BSI!
About the role:
Are you a Microbiologist, Sterilization Engineer, or Quality
Manager looking for an interesting career change? Then this could
be the opportunity for you!
Here at BSI we 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
This is a full-time position for a mid to senior-level professional
with competitive salary, annual bonus, and great benefits.
This role is Global home-based with 40-60% travel to client sites
(once COVID-19 restrictions lift) so candidates must be located
near a major airport.
Technical Specialist Responsibilities:
* Responsible for planning, reporting and performing of audits of
clients' management systems ensuring compliance with regulatory and
* Conduct comprehensive in-depth medical device reviews (including
* 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.
* A minimum of four (4) years' experience working as a
microbiologist and/or sterilization 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
* Ability to travel 40% to 60% via car and plane (when COVID-19
travel restrictions are lifted)
* ISO 13485 Lead Auditor preferred
* Quality management experience including significant participation
in third party quality audits
What we offer:
BSI offers a competitive salary, group-sponsored health and dental,
short-term and long-term disability, a company-matched 401k plan,
company paid life insurance, 11 paid holidays and 4 weeks paid time
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
BSI is an Equal Opportunity Employer and we are committed to
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.
Keywords: Environmental & Occupational, Arlington , Technical Specialist - Microbiology, IT / Software / Systems , Arlington, Virginia
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