Medical Device Quality Specialist - ISO 13485 - Oxford - £45k

Bond Williams Limited ,
Oxford, Oxfordshire
More Details
Salary: Up to £45000.00 per annum

Overview

A Medical Device Quality Specialist is required by an innovative start-up company in Oxford. The Medical Device Quality Specialist 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. Key Duties & Responsibilities Assist in ensuring compliance with the organisation'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. Develop and perform QMS training for employees. What we are looking for 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. Experience in handling and coordinating responses to FDA and ISO inspections. Bachelor's degree in science or engineering with 3-5 years of experience in quality systems/quality assurance in the medical device industry is required. Keywords: ISO 13485, CFR Part 820, FDA, Medical Device, Quality Assurance Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency

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