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Quality Engineer

Job Description

Key Responsibilities:

  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Quality lead on cross functional Value Improvement, Product Enhancement or New Product Introduction projects responsible for Test Method Validations, FMEA development, Validation review.
  • Use problem solving expertise to drive root cause identification for process and product issues
  • Approval of change requests for product, process and quality system changes.
  • Identification & utilization of key quality metrics in areas of responsibility to identify improvement opportunities.
  • Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Transfer and implement product and processes from development or from another manufacturing facility.


Educational Requirements:

  • Ideally will possess Bachelor of Science Degree in Engineering/Technology.
  • 3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 desirable.
  • Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
  • Experience/training in problem solving and process improvement methodologies.


For further Information on this role, please contact John on 021 4911065 or email

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