QMS Engineer - Johannesburg
She Recruits
We are looking for a Quality Systems Specialist to join our client’s incredible team If you have exposure and experience with software testing and also familiar with medical devices or pharmaceutical industry, then we want you Our client’s product is a smart 'anywhere' health monitoring system that allows users to create and manage a 360 degree of their health data, allowing them to monitor and make informed health decisions. Our client has created an incredible yet simple, easy to use system that their customers love Qualifications required: Diploma/BA/BS in life sciences, information technology, or relevant field STQB certified Skills and experience required: 5 years of relevant experience, preferably in the health or medical regulated environment Working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements – advantageous Previous experience implementing or administration of an eQMS software system – essential Experience and exposure with quality standards related to medical device software ie ISO 9001 & ISO 14971 & ISO 13485 (QMS) – essential Experience with IEC 62304 – advantageous Have experience in software testing - experience with software testing and Quality Assurance Working knowledge of Windows office system Have an awareness of Agile / Scrum methodologies or have worked in an Agile / Scrum Team. Technical experience with the Mobile and Web Application Development Atlassian tool suite (Jira, Confluence) Job description: 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 - 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 - 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.
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