Software Quality Engineer

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Our client a medical device manufacturer are looking for a Software Quality Assurance Engineer to be based in Chesterfield. As Software Quality Engineer you will drive all elements of software quality assurance support to manufacture a range of medical devices; including product development, manufacturing operations, information systems, and quality systems activities. As Software Quality Engineer you will ensure external and internal quality system requirements are adhered to throughout product and process lifecycles. Develop and implement software design plans, detailed design specifications, design verification/validation plans, test protocols/reports, traceability matrices and risk assessments. Additional emphasis will be placed on Software Validation activities. Perform risk assessments and validation assessments for product and process software changes. Lead the software risk management process throughout the entire product lifecycle. Lead a team through investigations and corrective actions for software related CAPAs. Leading the Software Quality Assurance function you will maintain a working knowledge of applicable regulatory standards and requirements. Maintain and continually improve Software Quality System procedures representing best practices and GMP, ensuring that the procedures meet all applicable regulatory standards and requirements. Develop development and training protocols and deliver to employees on principles of software validation, software risk management, and general software quality tools. Education & Experience:Ideally educated to degree level or have practical experience in in Quality Engineering, information systems, computer science or management preferably in a regulated industry. One year in a leadership role for product software validation and software quality assurance activities (desirable not mandatory)Working experience of regulations relating to in-vitro diagnostic medical device products and software (e.g. FDA's "General Principles of Software Validation and "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices , 21CFR Part820, 21CFR Part 11, EN ISO 13485, IEC 60601, EN ISO 14971:2012, IEC 62304). Emphasis will be placed on experience with the CE technical files.Experience in Software Development Life Cycle activities and understanding of software design inputs and outputs. Working knowledge of product software, analytical process software, manufacturing process software, and quality system software validation methods and requirement All listed tasks and responsibilities are deemed as essential functions to this position; however, reasonable accommodations will be made if at all possible under business conditions. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales