Job Summary
This is an exciting opportunity to join a leading multinational medical device organization based in Limerick. We are seeking a talented individual who is passionate about delivering high-quality products and services.
Key Responsibilities
* Develop and execute plans to improve product quality and process yield through the use of process characterization, optimization, problem-solving tools, and decision-making techniques.
* Identify and implement process-related continuous improvement activities to enhance product quality and increase Overall Equipment Effectiveness.
* E nsure that all process developments and improvements meet the Quality Management System requirements (ISO 13485, FDA & JPAL).
* Lead by example and demonstrate a strong work ethos within the team. Collaborate with personnel to resolve Corrective/Preventative actions addressing Quality, Technical, and Manufacturing issues (Audit Actions, NCRs, CAPAs, etc).
* Manage projects effectively, ensuring accurate planning, timely delivery, and reporting of project deliverables. Participate in risk assessments and HAZOPs of manufacturing processes and equipment.
* Develop and maintain Behavioural Standards aligned with company standards and policy.
* Maintain awareness of environmental and health & safety impacts of work performed. Stay updated on new developments and technologies in assigned disciplines and share Best Practice methodologies, procedures, processes, and equipment proactively.
Requirements
* Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical engineering with a minimum of 4 years' experience. Relevant experience with statistical process control and capability analysis is required.
* Achievement of Six Sigma/Green Belt/Black Belt accreditation would be highly beneficial.
* 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 is advantageous.