Quality Management System Administrator â Head
4 months ago
**Quality Management System Administrator Head Office**
***
**We are looking for a Quality Management System Administrator Fourways, Head Office**
- 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**
- Bachelors degree in a quality related discipline or bachelors 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
- 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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