Quality Assurance Representative
Luelle Consulting
Johannesburg, South Africa
3d ago
source : Job Placements

The Ideal Candidate

  • Must have + - 3 to 5 years of experience in the laboratory / medical device industry
  • Must have experience in Total Quality Management System Course
  • Must have practiced / maintained ISO 9001 & ISO 13485 QMS System
  • Duties include

    Maintain the Quality Management System

  • Ensure Medical and QMS is up to date both in soft and hard copy
  • Initiates populate, investigate, and manage Customer Complaint Register PCA register with new PCAs and follow up on outstanding PCAs raised internally and externally
  • Document & Record Control

  • Review, update, and create SOPs / SFs / WIs within the QMS when necessary
  • Training

  • Create training presentations relating to QMS principles
  • Provide the necessary training to Medical and Steri Solutions SA staff as per the Training schedule when the need arises or as per training schedule
  • Maintaining Approved Supplier List

  • Ensure the Approved Supplier’s List is updated with the relevant information
  • Completion of the QMS documentation when evaluating and approving Suppliers at Management Meetings
  • Conduct Internal Inspections

  • Identify the various sections that need inspection in a 12-month period
  • Create an internal inspection register
  • Raise PCAs and follow up on their investigation and closure with the appropriate evidence
  • Qualification

  • Matric / Grade12
  • Diploma or Degree in Microbiology / Pharmaceutical Sciences or Biochemistry (Advantageous)
  • Please note the above is the minimum criteria to be considered for the position

    NB - If you have not heard back from us in 2 weeks, please consider your application unsuccessful. Your CV will however be kept on our database for any future positions that may match your skills and competencies.

    Please note only shortlisted candidates will be contacted due to the large volumes of CV’s received.

    Motivation : Today I will do what others won’t, so tomorrow I can accomplish what others can’t

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