QA/RA Officer

Marketplace Technical ,
Newcastle upon Tyne, Tyne and Wear
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Job Description

Exciting Medical Devices Development company seeks a highly self-motivated and enthusiastic QA/RA Officer to be responsible for helping to maintain and improve the 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 QA/RA Officer will work with the Quality team and wider design development team through the design, development and launch of products, which will include compliance with the requirements of ISO 13485:2016 and BS EN ISO 14971 and IEC 62304. About the role: * Compile and maintain Medical Device Files, Technical Files and Device Master Records in preparation for Regulatory submissions in various markets globally with guidance from the Regulatory Manager. * Take an active role in the product risk management process. * Take an active role in software development compliance review and approval. * Support design review and control of change processes during product development. * Maintain an up-to-date awareness of relevant regulations which may impact the QMS and communicate this effectively. * Help to implement systems that facilitate productivity, improve processes and guarantee efficacy. * Be involved in and lead training sessions to ensure the understanding and compliance of all employees. * Administer, prepare, conduct and report internal quality system audits and external vendor assurance audits as necessary. * Work within the QA/RA team to maintain the company's electronic Quality Management System, Q-Pulse, including monitoring and progression of CAPA and audit actions. * Promote the benefits of the quality system to all employees. * Plan, conduct and report validation of QMS-related software packages. Duties may include: * Maintain a positive attitude and assist the QMS Manager to ensure deliverables are achieved within target timelines. * Champion the highest level of quality & process and undertake training in order to develop. * Work with the QMS Manager to identify and implement process improvements and efficiencies. * Manage individual projects and work packages as required. * Communicate effectively with all teams and functions. * Take a supporting role in the product risk management process including liaising with external SMEs and supporting risk management champions across the development teams in the risk management process. * Prepare, conduct and record internal system audits and participate in external vendor assurance audits. * Perform regular supplier reviews. * Maintain and administrate the electronic Quality Management System. * Promote the benefits of a quality system to all employees. * Take in interest in relevant Regulatory updates including contributing to assessment for impact on the company's QMS. * Effectively interact with Technical, Development, Manufacturing, Sales and Marketing, Operations and Finance teams to ensure processes are performed in accordance with company procedures. * Ensure tests and procedures are properly understood, carried out, evaluated and documented and that modifications are investigated if necessary. * Gather relevant data on QMS performance to facilitate statistical reporting where requested by the QMS Manager. * Actively participate in the asset management and control system including overseeing calibration and maintenance of assets as necessary. * Investigate instances of non-conformance, propose possible suitable corrections, corrective and preventive actions. Review and advise on potential instances of non-conformance. * Participate in 3rd party audits . * Help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files in preparation for Regulatory submissions in various markets globally with guidance from the VP QA/RA. * QA/QC review of both internal and contractor generated documentation relating to product development, validation and verification activities as well as device manufacture records when required. * Review and archival of records. * Support the administration of a company-wide risk-based comprehensive training system. * Help to design and deliver training sessions to ensure the understanding and compliance of all employees. * Take an active role in software development compliance review. * Support design review and control of change processes during product development. * Promote the benefits of the quality system to all employees. * Participate in and report validation of QMS-related computer software packages. * Work within the rest of the Quality team to maintain focused, effective progression in line with Company Quality objectives. * Support the Quality team by attending and providing feedback on training and mentoring activities. * Perform other duties that may be required from time to time. Skills and experience: * Experience of working with ISO 13485 is essential as is a good understanding of risk management for med

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