Quality Engineer – Medical Devices – with experience in a regulated industry required to join a leading Medical Device multinational based in Offaly. Working with a global team, the Quality Engineer with support quality engineering activities & compliance with global medical devices regulations. 

Responsibilities:

  • Working with a team, develop design verification & validation protocols for new and existing products & for product transfer
  • Conduct detailed root cause analysis and define corrective and preventive actions 
  • Conduct Internal audits and supplier audits
  • Develop inspection plans for incoming inspections
  • Detailed review and approval of Risk Managements files
  • Review and approval of change orders associated with components and manufacturing process
  • Provide Operational QA Support for products and process
  • Ensure quality manual & SOP’s are adhered to
  • Review & Approval of Change Orders associated with components & manufacturing process

 

Requirements: 

  • BSc. in Engineering (Biomedical, Mechanical or Electrical) 
  • 3-5 years of experience in a Quality Engineering role in a regulated industry (medical devices or pharmaceutical manufacturing)
  • Strong project management skills.
  • Demonstrated knowledge of statistical sampling and analysis.
  • Ability to work independently with minimal supervision.Accredited
  • Lead/Biomedical Auditor certification strongly preferred.
  • Knowledge of IEC 60601 electrical safety standards preferred.
  • Lean/Six Sigma certification strongly preferred.
  • Experience working in Oracle, Agile and TrackWise systems preferred
  • Knowledge of FDA regulations, ISO standards, CMDR, MDD and others.
  • Some travel is required.
  • Must be authorised to work in Ireland.

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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