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Quality Engineer

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20821

An exciting Quality Engineer role has arisen with a leading global medical device client in Cork.

Key Roles & Responsibilities:

  • Supervision of Quality Technicians and QC Inspectors.

  • 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). 

  • Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output. 

  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's).

  • Drive and implement plant wide quality system improvements.

  • Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).

  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).

  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques). 

  • Approval of change requests for product , process and quality system changes.

  • Customer complaints: analysis of returns, approval of analysis reports and analysis of complaint trends.

  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.

  • Compilation of required Regulatory documentation (E.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).

Education & Experience:

  • 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.

  • Excellent written and verbal communication skills

  • Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems

  • Strong command of MS Office – Word, Excel, PowerPoint.

  • Ability to rapidly learn and use new applications

For a confidential discussion and more information on the role, please contact Kevin Griffin

Kevin Griffin

(021) 2427108