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Collins McNicholas

SCOPE

Reporting to the Biotools QA Manager, the Senior Quality Engineer is responsible for managing the applicable quality group to deliver on achieving all key department metrics while also overseeing all Operational Quality Functions within the assigned area

 

Key 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.

 

  • Other duties as required.

 

Role 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

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

 

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