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QUALITY ENGINEER - 362643
Engineering / Mining / Industrial
Wage / Salary:
R - Market Related - P/M (Per Month)
A position is available for a Quality Engineer with 3 - 5 years experience and an Industrial Engineering, Quality Management qualification.
Duties & Responsibilities
Purpose of the position:
To assist with maintaining a company-wide quality management system (QMS) as well as assisting with medical device certification(s). This includes maintaining documentation of specifications and procedures, research and development, prototyping and keeping up to date with the latest local and international standards.
Increase company profitability by driving product success by designing efficient and scalable systems/products and ensuring on-time and on-budget delivery thereof. Takes ownership of assigned products and keeps a handle on product and project aspects including business models, specifications, budgets and financial models, progress tracking, management of resources and team capacity.
Desired: B Eng Industrial Engineering or similar
Minimum education essential: Diploma in Industrial Engineering, Quality Management
3 – 5 Years experience in:
Quality Management Systems (ISO 13485, ISO 9001, or similar) and regulated environments
Internal audit experience
Risk Management (ISO 14971)
Medical Device Software Life Cycle (EN 62304)
Business Analysis within the IT, software or medical device field
Development of project, product and system specifications
Requirement gathering and documentation
Essential Skills and Knowledge Required:
Excellent computer proficiency (especially in MS Office Excel)
Report and proposal writing skills
Business process design
Quality Management Systems (ISO 13485, ISO 9001, or similar)
Desired Skills and Knowledge Required:
Medical device regulatory (European MDD and US FDA)
ISO 13485 auditing certification
Agile Project Management
BPMN or UML Knowledge