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01.07.2021

QMS\Compliance manager

Onseo
IT

    ABOUT US

    AIBODY is a UK based company, newly spun out by the R&D team of the international technology group AUG Global. Driven by our desire to advance modern healthcare and save lives, we set out to conquer the limitations of existing medical simulation solutions. This led us on a mission to build the first of its kind Digital Physiology Platform capable of producing true-to-life responses and simulations. Now that our vision has become reality, we are able to access multiple opportunities to impact global healthcare priorities

    ABOUT THE ROLE

    As we prepare to move into the realm of Software As A Medical Device (SaaMD) with a focus on clinical decision support, we need to ensure compliance with all relevant international body standards and local regulation while seeking the quickest, regulatory compliant, route to market.

    Your initial objective will be to drive the business towards successful ISO 13485, FDA 21 CFR 820 and MDR accreditation. As such, you will take ownership of Quality Management for our digital physiology platform. This means taking responsibility for developing the Quality strategies, policies, processes, standards and systems for AIBODY and implementing a state of the art eQMS.

    This is a senior position where you will be working cross-functionally with other key members of the business as well as with suppliers, consultants, auditors, potential clients and of course, the regulatory bodies.

     Responsibilities will include:

    • Work with external consultants and vendors to develop, implement and execute a new eQMS
    • Prepare and implement internal policies and SOPs
    • Prepare and implement adequate Document, Design and Change Request Controls
    • At a later stage, prepare and implement processes for Non-Conformities and CAPAs
    • Provide internal QMS training to all staff
    • Support audit readiness (ISO 13485, FDA 21 CFR 820 and MDR)
    • Organise both internal and external audits
    • Act as the ISO and Regulatory standard Management Representative
    • Continuously maintain and improve QMS

    WHAT WE ARE LOOKING FOR

    You are an experienced Quality Manager with proficient understanding of medical device certification standards and regulation (particularly for US & EU). You are a strong self-starter who is comfortable working in a fast growth start-up environment and you have the knowledge, experience and ability to confidently make considered and robust decisions. You most likely have:

    • 3+ years of Quality Manager experience in the healthcare industry - ideally in a SaaMD company but could be medical device environment in general (must)
    • Previous experience in implementing or developing a Quality Management System (must) Proven knowledge of ISO13485 (must)
    • Highly developed communication and organisational skills (must)
    • Ability to continually evaluate the quality systems and maintain complete documentation to ensure the necessary controls are in place (must)
    • English fluency (must)
    • Ability to drive changes and inspire others to generate new ideas (must)
    • Experience in attaining ISO13485 accreditation for a business (will be a plus)
    • Proven knowledge of FDA 21 CFR 820 and MDR/MDD (will be a plus)
    • Experience in attaining FDA 21 CFR 820 and MDR/MDD certification (will be a plus)
    • Basic understanding of human anatomy and physiology (will be a plus)