• Global QMS Certification Lead - Medical Devices

    Contract Type
    Perm Full-Time
    Competitive salary plus bonus
  • The Opportunity

    Do you want to play a vital role in Medical Devices QMS Assessments globally for BSI?

    Do you have a great understanding of quality management systems (ISO 13485) and medical device regulation including the applicable country regulations and standards?


    If so, our new exciting role in our Global Medical Device QMS Team as a Global QMS Lead for the Netherlands could the the opportunity for you... This role is home-based and ideally you'll be based in the Netherlands.


    In this role you'll provide Medical Device Quality Management System leadership to Medical Device and QMS Assessment teams globally.  Your role comprises of two main elements; - 1) Leading projects and providing policy, input and expertise on Medical Device QMS assessments within existing and developing certification schemes, and 2) supporting the BSI RvA Accredited ISO 13485 certification scheme globally within ISO 17021 and other applicable accreditation rules.


    This will include leading on the alignment within BSI of relevant policies, procedures and documentation to meet its regulatory obligations and work with regional and global Medical Device management in the execution of relevant processes to meet these obligations.

    You'll provide Medical Device QMS mentoring and training to relevant BSI colleagues and support BSI’s implementation of QMS polices.


    You'll be the main point of contact for the delivery of Global BSI QMS Projects to BSI Medical Device clients; assisting QMS assessors, Technical Specialists, Scheme Managers, Sales, Marketing and other BSI Colleagues on Medical Devices QMS requirements.


    It'll will also be important for you to monitor Assessor capacity and competency to deliver assessments as well as provide assessment mentoring, to assist with support to QMS Assessors, Global Heads, Product Specialists and Scheme Managers on audits and certifications in area of expertise that may have a regulatory challenge.


    In addition you'll;

    • Deliver training programmes to BSI staff on auditing
    • Be a part of the execution of processes to deliver high quality QMS assessments services
    • Support technical delivery of Medical QMS Assessment processes


    The position also gives the opportunity to conduct around 25% travel annually to BSI and third party locations around the world (mainly EMEA) for business and representative meetings.

    About BSI

    Do you believe the world deserves excellence?


    BSI (British Standards Institution) has over 81,000 clients in 180 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

    To be successful in this role you'll have a comprehensive understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and Medical Device Directive, MDSAP, MDD, AIMD and/or IVDD requirements in particular).


    You'll have a good understanding of product and QMS certification concepts and principles, quality systems, philosophies and principles and internal auditing principles and practices including knowledge of BSI, its role and its approach to certification


    In addition knowledge of the application of accreditation/designation, notified body, product and quality systems standards and requirements are important along with a degree in engineering, science or related discipline.


    The ability to speak dutch is advantageous.


    What we offer:


    We offer a highly competitive starting salary and 15% bonus. We are offering 27 days annual leave with the opportunity to increase this to 30 days, company-paid private medical insurance, an excellent company-contributed pension scheme, and 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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