Medical Device Assessor | Client Manager / Medical Device Testing | Medical Devices | Assessor | Auditor | Quality Management
Are you currently a Design Engineer or Field Service Engineer looking for a new challenge?
Do you have hands-on experience in medical devices or related sectors (e.g. medical industry, healthcare, audit or research), including experience in the area of quality management? Are you based in Cologne or surrounding region in Germany?
If so, you can join our dedicated EMEA 13485 Assessment Delivery team and be trained to become a field based Medical Device Assessor using your extensive knowledge to support our Medical Devices clients while learning something new every day. 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.
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 R&D, engineering, design, production, quality and biotechnology backgrounds so you’ll be part of a diverse team that have a variety of skills and interests.
As a Medical Device Assessor you’ll visit our clients on a 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 management systems requirements.
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 offers a new experience.
When asked what is like to work at BSI as an Assessor, our Assessor's commonly use words such as ‘inspirational’, ‘rewarding’, ‘challenging’ and ‘professional’. 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.
Do you believe the world deserves excellence?
BSI (British Standards Institution) has over 81,000 clients in 182 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.
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 e.g. working within a certified QMS such as ISO 13485.
This experience must be focused on IVD medical devices.
Full time hands-on direct work experience can be in one or more of the following:
In addition you'll ideally hold a minimum of degree level qualifications, or equivalent, relevant to medical devices. For this role this would need to be in electrical engineering and/or computer and software technology or a closely related subject. Other qualifications might be in; electrical, mechanical or bioengineering / biology or microbiology / chemistry or biochemistry / computer and software technology / human physiology / medicine / pharmacy / physics or biophysics.
If you don't hold a degree level qualification, or equivalent, then the level of hands on experience as detailed above needs to be extensive in the region of at least 10 years.
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 Auditor training (if not already qualified) and with further MDSAP training.
We offer a highly competitive starting salary with 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.