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Hrr Solutions Limited
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Oxford, Oxfordshire
Quality Systems Specialist
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Salary: From £40,000 to £70,000 per annum |
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Overview
Quality systems specialist -Scientific, pharmaceutical, AI Our client is an innovative start-up company spun out of the University of Oxford. Their diagnostic imaging solutions is powered by artificial intelligence for cardiovascular disease. They are seeking a Senior Quality Systems Specialist who will implement and maintain the quality program and associated procedures to ensure overall compliance with ISO 13485, FDA Quality Standard Regulations (21 CFR Part 820) and other local, state, and international regulations and laws, associated with maintaining a marketed medical device. The role holder will report to the QA/RA Manager. Key Duties & Responsibilities Assist in ensuring compliance with the organization’s policies and all applicable national and international quality standards and regulations (i.e. ISO 13485, FDA 21 CFR Part 820). Assist in the development and maintenance of the document control process. Ensure complaints are investigated and resolved in a timely manner. Track CAPAs to ensure appropriate verification, implementation and follow-up on corrective actions. Develop and maintain QA standard operating procedures (SOP) and review SOPs generated by other departments. Conduct internal and external audits of the quality system. Collect information related to key QMS indicators and performance, including creation of periodic reports for management. Present at management review meetings information regarding the functioning of and impact of the quality system. Maintain knowledge of new developments in regulatory and quality standards that would have an impact on the operations and business. Develop and perform QMS training for employees. Identify and recommend opportunities for Improvement. This list of duties is not exhaustive and the post holder may be asked to carry out other duties through discussion with their line manager. Competencies Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices. Previous experience with management of Quality System documentation. Previous experience in managing and investigating complaints and CAPAs. Ability to effectively manage multiple and changing priorities. Ability to work in a high paced environment. Ability to collaborate to achieve objectives, problem-solve, and meet timelines. Understanding of the software development lifecycle Experience in handling and coordinating responses to FDA and ISO inspections. Strong interpersonal skills including a proven track record of building and maintaining effective working relationships with teams and industry partners. Bachelor's degree in science/engineering and/or 3-5 years of experience in quality systems/quality assurance in the medical device industry.