We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• The person has responsibility for the development and execution of plans to continuously improve and optimize product quality and process yield. This requires the use of process characterization and optimization using designed experiments, problem solving and decision-making tools.
• Responsible for identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
• Ensure all process developments and improvements meet the Quality Management System requirements (ISO 13485, FDA & JPAL).
• Demonstrate strong leadership and a clear identifiable work ethos within the team Engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues (Audit Actions, NCR s, CAPA s, etc).
• Project Management Accurate planning, timely delivery and reporting for all project deliverables. Participate in risk assessments and HAZOPs of manufacturing processes and equipment.
• Develop and maintain Behavioural Standards in line with company standards and policy.
• All employees are responsible for the Environmental and Health & Safety effects of the work that they perform Keep up to date on new developments and technologies in assigned disciplines and present on new Best Practice methodologies, procedures, processes and equipment to the company in a proactive manner.

• Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical engineering with minimum 4 years’ experience. Relevant experience with statistical process control and capability analysis required.
• Achievement of Six Sigma/Green Belt/Black Belt accreditation would be a distinct advantage.
• Excellent analytical and problem-solving skills, root cause analysis and risk assessments with a strong attention to detail.
• Familiarity with manufacturing and validation in a regulated (FDA or IMB) environment an advantage.