Are you currently a Quality Manager or Quality 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 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 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 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.
Medical Devices Assessor | Client Manager / Medical Devices Testing | Medical Devices | Assessor | Auditor | Audit | Auditing | Quality Management | ISO 13485 | Quality | R&D | Design Engineer | Field Service Engineer | Production Engineer | Medical Engineer | Product Manager | Product Development | Development Manager | Quality Manager | Quality Engineer | Mechanical Design Engineer | Designer | Software | Passive | Active | Scientist | Firmware Designer
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.
You'll need to be tenacious, have a passion to improve, taking pride in what you do and having a methodical approach to your work.
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.
Full time hands-on direct work experience can be in one or more of the following:
This direct hands-on experience above must be focused on a variety of the below medical devices;
Active - Infant warmers and incubators, X-Rays, Infusion Pumps, Surgical Lasers, Patient Monitors, Ultrasonic devices, RF and Cryosurgery devices, Telemetry devices, Anaesthesia Delivery Systems, Radiation Therapy devices, Surgical Robots, Patient Ventilators, Haemodialysis devices, Heart Lung machines, Defibrillators, MRI Scanners.
Active Implantable - Cochlear Implants, MEMS systems, Implantable neuro stimulator systems (spinal, brain, phrenic nerve, sacral nerve), Implantable infusion pumps, Implantable cardiac pacemakers and defibrillators, Implantable glucose monitors, Brachytherapy devices.
Software - Software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer; Treatment planning software that supplies information used in a linear accelerator is Software as a Medical Device; software that is intended for diagnosis of a condition using the tri-axial accelerometer that operates on the embedded processor on a consumer digital camera is considered Software as a Medical Device; Software used to "drive or control" the motors and the pumping of medication in an infusion pump; or software used in closed loop control in an implantable pacemaker or other types of hardware medical devices. These types of software, sometimes referred to as "embedded software", "firmware", or "micro-code" are not Software as a Medical Device; Software that enables clinical communication and workflow including patient registration, scheduling visits, voice calling, and video calling.
In addition you'll ideally hold a minimum of degree level qualifications, or equivalent, relevant to medical devices such as; electrical engineering and/or computer and software technology / 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.
You’ll need to be able to speak German at intermediate to advanced (B1 – C2) level along with good business English.
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.
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 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.