We are seeking an experienced professional to join our Medical Device organization based in Limerick. This is an exciting opportunity for anyone looking to work with a leading multinational known for its excellence.
Duties
* The ideal candidate will be responsible for developing and implementing plans to continuously improve and optimize product quality and process yield. This requires the use of process characterization, optimization using designed experiments, problem solving and decision-making tools.
* They will identify and implement 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).
* They will demonstrate strong leadership and a clear identifiable work ethos within the team. Engage with personnel in identifying and resolving Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues.
* 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 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.
Education & Experience
* A 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 advantageous.
* 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 would be an advantage.