Are you a Senior 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.
This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits.
This role is home-based with 50-60% travel to client sites so candidates must be located near a major airport. We are currently only considering candidates in the Northeast region of the USA.
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.
* 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 (MDR)
* Ability to travel 50-60% via car and plane
* 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 off.