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    Quality Systems Engineer - Cardiff, United Kingdom - ATL Technology (Cardiff, UK)

    ATL Technology (Cardiff, UK)
    ATL Technology (Cardiff, UK) Cardiff, United Kingdom

    6 days ago

    Default job background
    Description

    To provide support to the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP).


    • Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR).


    • Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820) and local quality standards.


    • Provide effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations


    • Provide reports to management to enable them to monitor system performance.


    • Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation.


    • Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.


    • Support and perform training throughout the company to maintain awareness of the Quality System requirements.


    • Support and conduct internal and inter-company Quality System Audits in line with local and group objectives.


    • Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP).
    • Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook.


    • All other essential duties as directed

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