Snr Quality Engineer

  • Cork
  • Permanent
  • JO-1905-64506_1561646572

Summary

RESPONSIBILITIES.

  • Supervision and talent development
    • Train, coach, organize and lead the assigned quality staff to achieve all required department targets.
    • Develop quality staff to focus on compliance, issue prevention, root cause analysis problem solving (RCA), attention to detail and team working ethic between quality and other dept functions.
    • Manage performance expectations and drive accountability across quality staff members.

  • Responsible for all operational quality aspects associated with product manufacture and release within the assigned area.

  • Responsible for the successful validation and qualification of process and raw material changes.

  • Ensures key quality metrics ( CAPA management, Right First Time, Complaints, etc) are attained.

  • Drive/support & implement continuous improvement projects with the operations team using Operational Excellence lean/six sigma tools.

  • Ensures the pertinent corporate quality and regulatory standards are attained.

  • Performs appropriate quality risk assessments and develops plans to deliver quality improvements within the area of responsibility.

  • Maintains strong communication with internal and external stakeholders.

  • Control the budget allocation to the area.

  • Participates / supports the Internal and External Audit Programme.

REQUIREMENTS:

  • A degree in an appropriate science/engineering discipline and at least 5 years relevant experience. Preferably in a regulated Medical Device or GMP manufacturing site.
  • Strong people management experience with ability to delegate tasks as required
  • Ability to develop and implement quality improvement programs
  • Excellent communication skills.
  • Good leadership and planning skills.
  • Technical ability and a good approach to problem solving.
  • Strong Statistical knowledge desirable.
  • Experience in use of Lean and 6 Sigma tools would be an advantage, GB certification an advantage

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