Quality Management System Administrator - North Johannesburg
Human Capital Solutions Africa
Our Client a Large Medical concern is seeking a Quality Management System Administrator Quality Management System Administrator -Organize, track, and maintain information concerning the various aspects of the Quality Management System (QMS) -Coordination and follow-up of procedures and other documentation associated with ISO13485:2016 including the management and coordination of the development of new documented processes required for continual improvement. Manage change of documents. -Timeous document, monitoring and reporting on the Corrective / Preventive Action, non-conforming product, and Complaints systems -Participate and perform internal audits as per the internal audit program. -Supplier audits when necessary -Responsible for control of internal and external documents -Champion organizational goals (quality objectives and key process indicators KPI’) and values -Support the Group RAQA Manager and/or other team members in various projects as assigned. -Support and supply data including statistical analysis of data for management review, take effective meeting minutes and track tasks. -Responsible for training of all employees concerning the QMS. -Implement the document change process effectively including the withdrawal, re-issuing and disposal/obsolete of documents and maintenance of the internal document register. -Aid in the manufacturing of devices (periodically) from planning to signing off final batch record documentation. Experience and Qualifications -Bachelor’s degree in a quality related discipline or bachelor’s degree in another discipline with quality experience -3 years minimum experience in document control and QMS experience -Expert level knowledge of ISO 13485:2016 -Preferable: CE MDD and MDR knowledge -Candidate must possess intermediate usage skills with Microsoft Office (Outlook, Excel, PowerPoint, etc.) -Self- disciplined professional working environment -Ability to compile routine reports and correspondence, ability to speak and write effectively and professionally and effectively work with diverse team members. -Good working knowledge of quality requirements and management systems for the manufacture and distribution of medical devices -Excellent written, verbal and communication skills -Attention to detail. -Ability to prioritize time efficiently, excellent problem-solving skills, adaptability to change with conditions and circumstances is essential in successfully performing this job. -Capable of working independently and willing to take initiative when discrepancies are found in the system. -Ability to learn new programs. -Must have experience in medical device manufacturing and related concepts of working in a cleanroom. -Must have experience in sterilization of medical devices (EO sterilization, compliance to ISO 11135). Language Skills: -Ability to read, analyse and interpret general business periodicals, professional journals, technical procedures, or government regulations. -Ability to write clear and concise reports, business correspondence, procedures and/or work instructions. -Ability to effectively present information and respond to questions from groups of management, associates, customers, and public. Reasoning Ability: -Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
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