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QE Manfacturing Engineer Career Profile

Quality Engineer (Manufacturing Support)


Quality Engineer in manufacturing provides operational support to manufacturing processes. In these positions Quality engineers will get exposure to technical transfers and scale up of products into full scale manufacture

Role/Responsibility

  • Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues
  • Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI)
  • Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ)
  • Ensure compliance of QMS procedures within the Business Unit
  • Lead Problem Solving meetings
  • Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed
  • Drive and implement plant wide quality system improvements
  • Participate in the development and improvement of the manufacturing processes for existing and new products
  • Coordination of PPAP activities
  • Provide functional expertise to other support function on quality related issues
  • Manage NCR Process
  • Interface with Suppliers for new processes, quality Issues and Process Improvements
  • Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved

Skill/Experience

  • Degree in Engineering, Science or equivalent is required
  • Minimum of 2 years experience in a QA role
  • Good level of technical and analytical skills
  • Problem Solving Skills and ability to handle multiple tasks in a fast paced environment
  • Capable of working as part of a multi discipline team