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    Quality Assurance Associate - London, United Kingdom - DNANUDGE

    DNANUDGE
    DNANUDGE London, United Kingdom

    3 days ago

    Default job background
    Description
    This is a Quality Assurance role NOT a Software role (The Quality Assurance Associate is responsible for helping to maintain and improve the DnaNudge Quality Management System as part of the Quality team by identifying potential improvements and efficiencies and helping to develop, revise and implement Quality procedures and policies.
    The Quality Associate will work with the Quality team to ensure products and design and development of future products are compliant with the requirements of ISOs 9001, 27001,

    Support strategy to enhance and maintain DnaNudge' s QA and regulatory programmes to meet required standards and regulations for products.

    Ensure the quality policy and processes support the strategic business plans to advance the company's mission and objectives.
    Work in close collaboration with all company departments to maintain compliance of all regulatory requirements.
    Participate in the execution and support of internal and external regulatory audits and inspections.
    Perform initial quality reviews of identified nonconformities.

    • Maintain knowledge of the site policies and procedures
    • Perform local area & local system audits where required
    • Proactive generation and timely review/implementation of change controls in conjunction with other personnel
    • Ensure that any documents presented for QA approval/checking are complete.
    Support a training program to ensure all employees are familiar with the relevant company processes.
    Support the maintenance of files for a range of quality records as required.
    Essential) Working with computer systems, MS office

    • (Desirable) Has worked in a similar role within the Medical Device/Pharmaceutical industry
    • (Desirable) Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints.
    • (Essential) In depth understanding of approaches to quality for legal manufactures
    • (Desirable) Knowledge of quality regulations (such as, ISO 13485, ISO 9001, ISO
    Business proficiency English with excellent written and verbal communication skills.

    • Flexible, with good time management skills and an ability to self-prioritize work.
    ·
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