QA Tester - Six Sigma and medical devices - She Recruits - North Johannesburg

Our Client, a meditech disruptor, is looking for a Quality Assurance Tester with Six Sigma experience in the medical field. In this role you will act as the administrator and SME as it relates to the configuration, implementation, analysis as well as the maintenance of our electronic quality management system (eQMS). Education Diploma/BA/BS in life sciences, information technology, or relevant field – essential. Six Sigma certified or solid experience – essential. ISTQB certification – advantageous. Experience 5 years of relevant experience, preferably in the health or medical regulated environment Experience and exposure with quality standards related to medical device software ie ISO 9001 & ISO 14971 & ISO 13485 (QMS) – essential. Serve as QA subject matter expert (SME) for eQMS. Experience of working in an Agile / Scrum team. Technical experience with the Mobile and Web Application Development. Working knowledge of Windows office systems. Atlassian tool suite (Jira, Confluence). Knowledge: Working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements - advantageous Responsibilities: Act as committee chair or member for all software steering committees which have an impact on the quality system. This includes participating on all teams to modify or upgrade the system. Responsible for maintaining the eQMS system and performing tasks related to continuous improvement of this electronic QMS system. Develop or review protocol, plans, scripts, reports, SOPs etc. associated with the implementation and maintenance of computerized systems. Serve as the QA contributor on projects including inquiries pertaining to the interpretation of regulatory requirements for computer system validation. Execute document and change control processes to ensure standardization, accuracy, and completeness of documents prior to release. Assist in the execution and/or review of computer system validation documentation. Assist in training other departments in the use of the electronic documentation systems. This includes providing one-on-one training as well as group training Review and evaluate reports from the documentation and change control systems and other information as deemed necessary. Investigate trends, prepare reports and notify management of issues needing further review. Assist in preparation for Quality Affairs Committee and attend QAC meetings; take minutes and prepare meeting minutes. Continuously evaluate areas of responsibility and recommend improvements to the processes concentrating on efficiency and quality of the product and/or systems. Ensure Key Performance Indicators measure progress against Quality objectives. Support and facilitate change control processes. This includes partnership with change control owners to assist them in the development and execution of change controls or completion of tasks. Please consider your application unsuccessful if you have not heard from us within 1 week. We will keep your details on file for future positions. Apply Now

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