Posted on Jul 30, 2020 by BSI West
Great that you're thinking about a career with BSI!
BSI is hiring a Medical Device Sterilization Auditor/Microbiologist (known internally as Technical Specialist - Microbiology) to join our global Medical Devices team. This role is home-based with 60% travel to client sites and training. At this time we are only hiring candidates currently living in or willing to relocate to Denver, Colorado.
Click here to learn more about our Microbiology and Sterile Medical Device services.
The Technical Specialist is a senior-level individual with at least four years of sterile medical device experience and he/she serves as a subject matter expert in the area of sterilization and microbiology for medical device reviews and third party ISO 13485 quality audits.
This position is a full-time salaried role with a comprehensive benefits package.
- 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). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work.
- Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective.
- Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client.
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 (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED)
- Bachelor's degree in Microbiology, Biology or related scientific degree
- Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR)
- Ability to travel 60% via car and plane
- ISO 13485 Lead Auditor preferred
- Quality management experience including significant participation in third party quality audits
BSI is an Equal Opportunity Employer and we are committed to diversity.
To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.