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Technical Specialist – Microbiology (Colorado)

BSI West

This is a Contract position in Boulder, CO posted September 20, 2020.

Great that you”re thinking about a career with BSI!

Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team!

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.

This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport.

Essential 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). 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.

Education/Qualifications:

  • A minimum of four (4) years experience working as a microbiologist (or sterilization engineer) for asterile medical device manufacturer (REQUIRED)
  • Bachelors degree in Microbiology, Biology or related scientific degree (REQUIRED)
  • 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

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 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.

by Jobble