EQMS Champion/QMS Engineer (sometimes also known a

Our client a Tech firm in the medical solutions space is seeking a eQMS Champion/QMS Engineer (sometimes also known as QMS Specialist Medical Devices or Systems) to join their team in Rosebank. They offer stability, growth, attractive salary with great benefits such as medical aid, provident fund, etc. if you have exposure and experience with software testing and also familiar with medical devices or pharmaceutical industry. We are looking for a Quality Systems Specialist. 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). You will provide quality oversight and also be responsible for managing the “late Items” program, monitoring the due dates for all types of investigations, change controls and other controlled documents, ensuring items are closed within the approved timelines. Requirements * Working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements - a bonus * Previous experience implementing or administration of an eQMS software system - a must * Experience and exposure with quality standards related to medical device software ie ISO 9001 & ISO 14971 & ISO 13485 (QMS) - a must! * Experience with IEC 62304 - a bonus * Must have a Diploma/BA/BS in life sciences, information technology, or relevant field with 5+ years of relevant experience, preferably in the health or medical regulated environment * Six Sigma certified - a must or have related experience to prove same * Serve as QA subject matter expert (SME) for eQMS. 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 recomm