Technical occupations |
Engineers and Scientists |
Technicians |
Machine Operators and Assemblers |
Key roles |
� Product research and development
� Production and manufacturing engineering
� Design of automated production processes
� Validation engineering � Quality engineering � Production management and troubleshooting � Regulatory bodies requirements compliance management
� Standard Operating Procedures( SOP) development and compliance
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� Production processing � Production data collection
� Production technical inspection
� Production equipment maintenance and troubleshooting coordination
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Machine Operators
� Operate and monitor machinery and equipment � Production raw materials handling
� Equipment and clean room routine maintenance and sanitation
� Production waste handling
Assemblers
� Assemble prefabricated parts or components to form products and equipment
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Knowledge / skills required |
Skilled
� Understand the needs and requirements of the industry
� Regulatory affairs and the related auditing process
� Quality in the medical devices regulatory environment
� Product development in the medical devices regulatory environment � Clinical trials � Intellectual property � Communication skills � Analytical skills � Problem solving skills
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Skilled
� Fundamental knowledge of products and the industry
� Basic understanding of medical devices regulatory affairs
� Design and manufacturing of medical devices � Good manufacturing practice and good laboratory practice � Problem solving skills
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Semi-skilled
Machine Operators
� Basic understanding of the machines and ability to operate them
� Ability to identify visible problems with the products / semifinished products generated by the machines
Assemblers � Manual dexterity � Ability to read and comply with the assembly instructions
� Sufficient awareness to identify visible problems with components and assemblies
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