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    Quality Manager - Reading, United Kingdom - Humand Talent

    Humand Talent
    Humand Talent Reading, United Kingdom

    1 week ago

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    Description

    Do you have some experience working with software as a medical device?

    Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.

    My client is looking for a driven and detail oriented Quality Manager to join there team

    They are looking for a highly talented The Quality Manager to manage a small team and report to the Head of the QARA Team.

    If you also have experience managing a small team of Quality Engineers, please read on

    Main tasks and area of expertise:

    • Maintaining the MDSAP and ISO 13485-certified Quality Management System.
    • Ensure all procedures are up to date with changing standards and regulations and are being implemented by all employees.
    • Supporting the management of the Information Security Management System alongside the Information Security Officer (as per ISO
    • Facilitate management reviews, notified body audits, supplier audits, and internal audits.

    Essential

    • Prior experience of working for a small to medium-sized medical device company in quality or compliance-based role.
    • Experience with software as a medical device or medical device with software and knowledge of Medical Device Regulations (EU MDR, US CFR 21 Part 820 and/or other global medical device regulations).
    • External and internal audit experience, including hosting notified body audits, and conducting supplier quality assessments.
    • Knowledge of quality standards including ISO 13485 and ISO 14971

    Advantageous

    • Qualification in regulatory affairs or quality assurance
    • Knowledge of MDSAP regulations

    If this sound like a good fit for yourself please click apply or drop me a message and arrange a chat. would love to hear from you.

    Humand Talent Solutions and their clients and associates do not discriminate on any of the following and any terminology that suggests that should be made aware to our business ASAP.

    Categories include:

    · gender

    · race

    · religion or belief

    · disability

    · age

    · pregnancy and maternity

    · marriage and civil partnership

    · sexual orientation

    · gender reassignment

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