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QA Auditor - Medical Device (IVD)

at bsi.

Posted: 7/26/2019
Job Reference #: 11307
Keywords: compliance

Job Description

  • Location(s)US-TX-Fort Worth
    Category
    Healthcare
    Contract Type
    Perm Full-Time
    Hiring Manager
    Danielle Snyder
  • The Opportunity

    BSI Americas are recruiting for medical device professionals who have directly been involved in the design, manufacture or research and development of IVD medical devices who want to transition their expertise to a notified body and ensure patient safety.

    This career path would lead you to qualify as an ISO13485 Quality Assurance Auditor in our Service Delivery Team. You’d travel to medical device manufacturers across the continental United States to ensure that they meet regulatory requirements such as: CMDCAS, MDSAP, and 510(K).

    If you enjoy travel, being a subject matter expert and being part of a growing global team then this could be an ideal career opportunity to consider.

    About BSI

    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.

    As a Quality Assurance Auditor, you’ll have the opportunity to thrive in a highly regulated and challenging environment where your contributions are really valued. BSI’s clients are based in a variety of locations across the USA to include: Texas, Massachusetts, Kentucky, Illinois, Iowa, Wisconsin, New York and more.

    The ability and desire to travel extensively is a must. Travel is an essential part of this role and you’ll go via land (car) and air to get to different customer sites across the US.

    As part of our Medical Device team you’ll help ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has also successfully achieved designation as a Notified Body in The Netherlands and is an accredited ISO 13485 Certification Body and is recognised in many global markets.

    About You

    The qualities we look for in our medical device professionals are:

    • Tenacity, have a passion to improve, taking pride in what you do and having a methodical approach to your work;
    • Confidence, 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 and required for this role.

    You must have a minimum of 4 years of full-time “hands-on” work experience in the field of medical devices or related sectors (e.g. medical industry, R&D, production, healthcare).

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

    • Research and development, manufacturing, service & installation;
    • 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.

    This experience must be with IVD medical devices. You can find more information on the devices here: Medical Device - In Vitro Diagnostic

    Due to strict regulatory requirements, only candidates with degrees in: biology, microbiology, chemistry, biochemistry, computer and software technology, electrical/electronic/mechanical or bioengineering, human physiology, medicine, pharmacy, physics or biophysics, will be considered for this role.

    You must have a full US driving license and be prepared to meet the 100% travel requirement to and from clients across the US via land (car) and air travel.

    If you are passionate about ensuring patient safety, visiting different states and enjoy helping top medical device manufacturers obtain and maintain excellent standards then apply to ensure you are considered to become part of our devoted Medical Devices Service Delivery Team.