• Responsible for all operational quality aspects associated with product manufacture and
• Responsible for the successful validation and qualification of process and raw material
• Investigate Quality problems associated with the production department and implement
effective corrective and preventive measures
• Support introduction of new products into the site ensure products are designed and
validated to the required quality and regulatory standards.
• Ensures key quality metrics ( CAPA management, First Pass Quality, Complaints, etc) are
• Drive/support & implement continuous improvement projects with the operations team
using Process Excellence lean/six sigma tools.
• Ensures the pertinent corporate quality and regulatory standards are attained.
• Maintains strong communication with internal and external stakeholders.
• Participates I supports the Internal and External Audit Programme.
• Apply G.M.P. and observe that it is being adhered to in the department.
• Participate in teams to help make necessary improvements and changes to all process
related issues in the production department.
• Identify and Implement continuous improvements in conjunction with the operations team.
• Liaise with Vendors and Customers on quality related issues, internal and external.
• Supervises team of Quality Techs inspectors as required.
• Additional duties as required.
CANDIDATE’S PROFILE Requirements
Third level qualification or relevant knowledge and experience of Medical Device Directives; Previous
experience in a similar role is desirable; Good investigative and problem-solving skills; Good
Communication skills; Computer literate.