• Global MDSAP Certification Lead - Medical Devices

    Location(s) US-VA-Herndon
    Contract Type
    Perm Full-Time
    Closing Date
  • About the Role


    Job Title:      Global MDSAP Certification Lead - Medical Devices

    Reports to:   Global MDSAP Program Manager - Medical Devices


    Purpose of the position

    • Provide support to the Global MDSAP Manager in execution of MDSAP globally.
    • Assist with the global Medical Devices MDSAP initiative for BSI, supporting co-ordination and embedding of requirements in BSI systems and processes
    • Support alignment within BSI of relevant policies, procedures and documentation to meet its MDSAP regulatory obligations and support work with regional and global Medical Device Management in the execution of relevant processes to meet these obligations
    • Provide Medical Device MDSAP mentoring and training to relevant BSI personnel
    • Support BSI’s implementation of MDSAP and transition of CMDCAS for existing clients in the MDSAP scheme consistent with requirements of other QMS schemes, e.g., UKAS, RvA and SCC.
    • Support the delivery of training programmes to BSI staff on MDSAP auditing
    • Assist with execution of processes to deliver high quality MDSAP assessments services
    • Support technical delivery of MDSAP processes, including quotations and audits
    • The position is EMEA based and will involve some travel to BSI and third party locations around the globe for business and representative meetings


    Key Responsibilities & Accountabilities

    • Support the Global MDSAP Program Manager to Lead and manage the Global BSI MDSAP initiative
    • Assist the global teams in delivery of a robust and responsive MDSAP service to BSI Healthcare clients
    • Provide input and expertise to the Global Medical Devices Team
    • Assist QMS assessors, Technical Specialists, Scheme Managers, Sales, Marketing and other BSI Colleagues on MDSAP requirements
    • Interface with QMS Assessors and Scheme Managers fielding questions from their clients
    • Monitor resource / delivery of MDSAP audits
    • Monitor MDSAP Assessor capacity and competency to deliver MDSAP assessments in support of regional demands
    • Provide MDSAP assessment mentoring in areas of competence to personnel in the BSI medical devices stream
    • Assist with support to QMS Assessors, Global Heads, Product Specialists and Scheme Managers on MDSAP audits and certifications in area of expertise that may have a regulatory challenge
    • Support MDSAP Program Manager in execution of actions from external meetings with third parties and effective handling of issues that arise
    • Assist in the creation of BSI messaging regarding MDSAP for sharing externally at meetings and conferences.


    Key Result Areas

    • Management of the MDSAP including support processes and procedures to be a fully compliant with Regulator requirements with no systematic non-conformities at audit
    • Encourage consistent medical devices quality systems assessments and provide expert QMS advice or briefings as needed
    • Delivery of all services to time and quality, with positive feedback from clients and colleagues
    • Thorough, prompt reporting back from meetings with third parties and effective handling of issues that arise
    • Timely handling of projects falling within area of specialism


    Key Performance Indicators


    • Annual business financial KPIs
    • Operational KPIs
    • Regulator audit results – Fully compliant MDSAP Operation with no systemic non-conformities at audit
    • Medical device internal training programme success
    • Positive relationship with Global and regional management colleagues maintained as program grows


    About BSI

    Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently run, growing business. BSI has come a long way since being founded in 1901. Today, we are a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.


    With over 3,300 employees working with over 80,000 clients in 172 countries, it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.


    Our Vision: "Making excellence a habit", it describes our way forward and our aspiration each day.

    Our Mission: "To help organizations embed excellence", and states our shared purpose.

    Our Values: "Integrity - Continual improvement - Inclusivity", guide us in the way we work and help us deliver our Vision and Mission.


    What we offer:

    BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.


    BSI is an Equal Opportunity Employer and we are committed to diversity.


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