Job Description

The Consultant shall be responsible for, amongst other things:

  • Designing manufacturing processes, developing procedures and production layouts for manufacturing, equipment installation, processing, machining and material handling;
  • Designing arrangement of machines within the plant facility to ensure most efficient and productive layout;
  • Document development work including writing specifications for manufacturing or scientific test results.
  • Inspecting the performance of machinery, equipment, and tools to verify their efficiency, and investigating and initiating corrective action of problems and deficiencies to ensure product quality;
  • Determine the financial impact of potential decisions and act accordingly.

Preferred skills

  • Experience in the Medical Device industry;
  • Quality systems engineering experience in manufacturing environments
  • A critical thinker and active listener with good time management skills in order to work with Suppliers, Production Teams and Project Management teams to define deliverables;
  • Strong project management and leadership skills;
  • Experience with Advanced Quality Process (APQP) tools and the Metrics to proactively identify and help implement improvements to Quality Systems, Methods, Tools and Processes;
  • Experience with Process Failure and Effects Mode Analysis (PFMEA);
  • Experience with Design Failure and Effects Mode Analysis (DFMEA);
  • Strong analytical problem-solving skills and expert in the use of Non-Conformance, SCAR, CAPA and root cause analysis tools;
  • Advanced knowledge of quality related tools including, but not limited to root Cause Analysis
  • PQ, IO and OQ validation procedures, test script documentation and audit management.

Preferred Experience

  • 5+ years in a manufacturing environment.
  • Experience in setting up a manufacturing facility in the medical sector.

 Qualifications

  • Bachelor’s degree in Industrial Engineering
  • A Master’s degree is advantageous.

 EMail applications to Lorraine Nagel : lorraine@dglhr.co.za

 

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