Medical Devices Technical Specialist - Microbiology
bsi
Dortmund, DE
vor 6 Std.

The Opportunity

Due to continuing strategic growth within our Medical Devices business, we currently have a vacancy for a Technical Specialist within the Microbiology team.

This is an excellent opportunity to join a leading Certification Body and European Notified Body, to be driving up the standard of safety and performance of Medical Devices for patients around the globe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.

This role is a home based role within Europe ideally in the UK, France, Germany, Netherlands or Italy. A high proportion of travel is required to visit client manufacturing sites across Europe, Middle East and Africa.

As the Technical Specialist - Microbiology you will be arranging and performing on-site audits of Quality Management Systems and Sterilisation Processes.

You will also be involved in the review and evaluation of manufacturers’ medical device technical documentation. Your decisions will influence which products go to market.

Working with a variety of medical device manufacturers throughout Europe and globally, you will be evaluating a wide range of product types and will need commitment to delivering a diligent and timely service.

The fast paced nature of this rewarding role will eventually require you to work autonomously with manufacturers as they execute their go to market’ plans.

The role requires the Technical Specialist to be efficient and effective in; comprehending product and process information, identifying and challenging risks and making conclusions regarding product safety.

The role requires the Technical Specialist to provide a critical, but common sense, evaluation of the information provided by the manufacturer to demonstrate conformity with applicable regulations or standards.

About BSI

BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe.

  • BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical device;
  • active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others.

    The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results.

    There is exciting opportunities for further growth of the Medical Devices team.

    About You

    To be successful in this role you will need to apply the significant knowledge and hands on’ experience that you have gained in medical devices industry.

    You will need to assess, evaluate and report on client products, applying the principles of process control, process validation design control and risk management,.

    The right candidate will have demonstrated strong inter-personal and communication skills. You will need a solid foundation of experience within Microbiology in the manufacturing, design, and development of medical devices.

    Your experience should include implementation of Regulatory requirements and Standards for sterile and microbiologically controlled products.

    You will hold a BSc, Master’s degree or PhD (or equivalent qualifications) in microbiology. We offer a highly competitive starting salary of up to £62,000 / €76,000 (depending on experience and location) plus 10-

    15% bonus. BSI also offers employees; a generous 27 days annual leave (with the opportunity to increase this to 30 days), company-

    paid private medical insurance, an excellent company-contributed pension scheme, and a wide range of flexible benefits that you can tailor to suit your life-

    style. We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers.

    As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.

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