BSI is hiring a Medical Device Sterilization Technical Specialist to join our global Medical Devices team. This role is homebased with 60% travel to client sites and trainings. We strive for local travel by car whenever possible.
The Technical Specialist serves as a subject matter expert in the area of sterilization and microbiology for medical device reviews and third party quality audits. This role is perfect for a mid to senior level professional who began their career as a Microbiologist in a medical device or pharmaceutical setting with significant exposure to quality audits such as ISO 13485 and ISO 9001. Candidates should have several years of hands-on experience with sterilization validation, microbiology testing, packaging validation, and sterilization techniques such as gamma, e-beam, steam, ethylene oxide and aseptic.
In this role you will be part of a high performing and highly professional team that cares deeply about providing superior services to our clients, patient safety, and continual learning. The Technical Specialist role reports to the Microbiology Technical Team Manager and has frequent interactions with fellow Technical Specialists, QA Auditors, and Client Services Coordinators.
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.
BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected worldwide for the development of quality standards; assessment of management systems; testing and certification of products and services; software solutions; training courses, supply chain management, and environmental, health, and safety consulting. BSI is a private company incorporated by Royal Charter which means we are a professional institution with pre-eminence, stability and permanence in our field.
With around 4,000 employees working with over 80,000 clients in 172 countries, BSI embraces diversity and offers vast opportunities for career growth.
Our Vision: "To be the global business improvement partner of choice.”
Our Mission: "To help organizations embed excellence", and states our shared purpose.
Our Values: "Integrity - Continual improvement - Inclusivity", guide us in the way we work and help us deliver our Vision and Mission.
What we offer:
BSI offers a competitive salary, group-sponsored health insurance, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, paid holidays and paid time off.
BSI is an Equal Opportunity Employer and we are committed to diversity. #LI-MSFITZ
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.
Qualifications and Education Requirements:
A minimum of five (5) years’ experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer
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)
Ability to travel 60% via car and plane
Preferred Skills & Experience:
ISO 13485 Lead Auditor
Quality management experience including significant participation in third party quality audits