BSI Group

EMEA Medical Devices Assessor - Active & Software Devices (m/f)

DE-Frankfurt
Kategorie
Healthcare
Vertragsart
Perm Full-Time

Über das Team

Do you believe the world deserves excellence?

BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Renowned for its marks of excellence including the consumer recognized BSI Kitemark, BSI’s influence spans multiple sectors including Aerospace, Automotive, Built Environment, Food, Healthcare and ICT. With over 81,000 clients in 182 countries, BSI is an organization whose standards inspire excellence across the globe.

Über die Position

Assessment Delivery is the largest part of our UK business, and we’re looking to grow further therefore creating a number of exciting opportunities for you to join our team as an EMEA Medical Device Assessor focusing on Active and Software Devices, you’ll be home based in Germany.

 

The 13485 Medical Device QMS Assessment Team is one that covers the EMEA region. The team is made up of a group of assessors with science, engineering and biotechnology backgrounds so you’ll be part of a diverse team that have a variety of skills and interests.

 

The regulatory environment is changing rapidly at present and, as we continue to grow, we’re looking for talented, client-focused people who understand the challenges businesses are facing, to join our team of Assessors.

 

You’ll visit our clients on an almost daily basis, travelling to their sites and gaining a real understanding of their organisation. By understanding their business and their challenges you’ll be able to help them improve their performance by assessing their organisation or products against our management systems.

 

Deep and broad technical knowledge together with a passion for excellent customer service is vital.  the assessor role is a rewarding, challenging job and there’s never a dull day - each client is different, so each day and each assessment is different.

 

When asked what is like to work at BSI our Assessors commonly use words such as ‘inspirational’, ‘rewarding’, ‘challenging’ and ‘professional’.

Über Sie

To be successful in this role you will need to be tenacious, have a passion to improve, taking pride in what you do and having a methodical approach to your work. You’ll have the confidence to communicate with all levels within a business, and discuss how you can help them to improve their organisation.

 

We help our clients achieve best practice so that means you’ll need to have the ability to assimilate, articulate and present information at a high level.  You’ll be working constantly with clients so excellent interpersonal skills as well as strong verbal communication and written report writing skills are also essential.

 

Having the knowledge and experience in the Medical Devices industry is vital. You’ll have a minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management. This experience must be focused on Active and/or Software medical devices.    

 

Full time hands-on direct work experience can be in one or more of the following:

 

  • Research and development, manufacturing, service;
  • the application of the device technology and its use in health care services and with patients;
  • testing the devices concerned for compliance with relevant national or international standards;
  • conducting performance testing, evaluation studies or clinical trials of the devices.

 

In addition you'll hold a minimum of degree level qualifications, or equivalentrelevant to medical devices. For this role this would need to be in electrical and/or computer and software technology.

 

Of course, as our clients are based in a variety of locations the ability and desire to travel extensively is also a must as travel is an essential part of the role which frequently includes overnight stays.

 

Our Medical Device Assessors are dedicated individuals who are motivated to go beyond their formal job responsibilities and deliver excellence to our clients. It’s a challenging, yet extremely rewarding role.

 

What we offer:

 

We'll give you all the training and support you need to build your career with this dynamic and growing organisation. You'll be provided with Lead Audior training (if not already qualified) and with further MDSAP training.

 

We offer a highly competitive starting salary with bonus and company car as well as 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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