QA Officer

Job Description

QA / RA OfficerBased in Liverpool PermanentMonday - Friday 8:30am - 4.30pm Competitive salary - please get in touch for detailsParking onsite, private medical, life assurance, company pension, attendance bonus Our Client, an established Medical Devices company / IVD are looking to recruit for an additional experienced QA Officer to work at their modern R&D facility based on the outskirts of Liverpool. The role also includes additional duties across RegulatoryAffairs in relation to Medical Device regulations.Duties:

• The successful QA / RA Officer will work closely with Quality Assurance Manager and assist in ensuring that all aspects of Clients Group QMS remain effective.
• Assist in maintaining compliance with all applicable Quality standards regulatory and statutory requirements necessary to the continued business activities of the Client.
• Assist in ensuring that all documents and information relating to customer regulatory requirements are generated and available as required.
• Investigate and rapidly resolve all complaints relating to Clients products and services, ensuring that the necessary CAPA measures are identified, documented, logged and actioned in a timely manner, in accordance with the Client Group Quality ManagementSystem (QMS) requirements and appropriate regulatory requirements.
• Work with R&D staff in the compilation / storage and accessibility of regulatory required product Technical Files.
• Provide support and advice to Company departments in regulatory matters, as required.
• Assist with promoting the principles of regulatory requirements to all staff in conjunction with the QA&QARA Managers, under the overall direction of Top Management (Client Company Directors).
• Work alongside and under the direction of the QA/QARA Managers in any of the following activities as required; identifying and ensuring compliance with all applicable standards, regulations and directives, relating to IVD medical device products, QMS, andother statutory legislation e.g. health and safety at work and environmental management; Ensuring that Clients products are designed, manufactured, marketed, sold and shipped in compliance with current IVD medical device regulatory requirements and otherapplicable regulations and standards.
• Ensure that Clients products are registered in accordance with all relevant national requirements for each country.
• Assist the QARA team in managing product vigilance issues, including field safety notices, customer advisory notices and liaison with National Competent Authorities as required.

• Work with QA/QARA Managers, as required, on any QARA related activities, such as Internal Audits, Document Control, Non-Conformance, Supplier Approval etc.
• Work with Research and Development, and Quality Control staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements.
• Working as part of the QARA Team to provide support and advice to Company departments in regulatory and quality assurance matters, as required. This includes equipment calibration and monitoring: process verification and validation; document training; Investigationand rapid resolution of complaints relating to Clients Group products; recall and vigilance reporting and liaison with National Competent Authorities as required; ensuring that necessary improvements and corrective and preventative (CAPA) measures are identifiedand implemented; Internal audit scheduling.

Qualification and Experience:

• Minimum educated to Degree level in a Life Science (Biomedical, Microbiology, Biotechnology, etc) subject.
• A solid understanding of ISO 134845, 9001, 17025 standards and working to these QMS.
• Will have worked in the IVD/ Diagnostics sector.
• The ideal Candidate will have previous regulatory experience.
• Experience in raising non conformances, CAPAs etc is desirable.
• Strong report writing skills, and communicative skills required.
• Will be IT proficient working across a range of softwares and applications.

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