• Assessor - IVD and Organic Medical Devices

    Location(s)
    IT
    Category
    Healthcare
    Contract Type
    Perm Full-Time
    Salary
    Competitive Package
  • The Opportunity

    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?

     

    Do you want to part your knowledge with the Medical Device industry while learning something new everyday? Are you based in the Stockholm, Malmoe, Lund or other region of Sweden?

     

    You can join our dedicated EMEA 13485 Assessment Delivery team as a field based IVD and/or Organic Medical Device Assessor.

     

    Assessment Delivery is a large part of our business, and we’re looking to grow further therefore creating a number of exciting opportunities.

     

    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 our management systems.

    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.

     

    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 as an Assessor, our Assessor's commonly use words such as ‘inspirational’, ‘rewarding’, ‘challenging’ and ‘professional’.

     

    Medical Device Assessor | Client Manager / Medical Device Testing | Medical Devices | Assessor | Auditor | Quality Management | ISO13485

    About BSI

    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.  

    About You

    • 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;
    • Confident, able to communicate with all levels within a business;
    • Able to assimilate, articulate and present information at a high level;  
    • Excellent interpersonal skills as well as strong verbal communication and written report writing skills.

    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 and/or Organic medical devices as detailed below;

     

    IVD - IVD Devices intended to be used for self testing / IVD Devices to be used as companion diagnostics / IVD Devices utilizing material of human origin / IVD Devices in sterile condition / IVD Calibrators / Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes / IVD instruments, equipment, systems or apparatus / IVD Software independent of any other device (Apps, software for data analysis, software for defining or monitoring therapeutic measures. / IVD Devices incorporating software / Biotechnology / IVD packaging/labelling

     

    Organic - Non-metal mineral processing including glass, ceramics / Non-metal, non-mineral processing including textiles, rubber, leather, paper / Biotechnology / Chemical processing / Production of parmaceuticals / Processing of materials of human or animal origin

     

    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.

    You'll also hold a minimum of degree level qualification, or equivalent, relevant to medical devices. 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 expereince to be extensive in the region of at least 10 years hands-on medical device experience, or employed in an audit, inspectional or enforcement position for a regulatory authority whereby you have acquired and demonstrated significant in-depth knowledge of medical device design and manufacturing, as well as the evaluation of compliance of medical device manufacturers to standards and regulations.

     

    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.

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