We are recruiting for a key role with an award-winning Medical Device organization based in Limerick.
This position offers the opportunity to join a leading multinational company that excels in its industry.
Duties
* Develop and execute plans to continuously improve and optimize product quality and process yield using process characterization, optimization, problem-solving tools, and decision-making strategies.
* ID and implement process-related continuous improvement activities to enhance product quality and increase Overall Equipment Effectiveness.
* Evaluate all process developments and improvements against Quality Management System requirements (ISO 13485, FDA & JPAL).
* Demonstrate strong leadership and work ethos within the team. Collaborate with personnel to resolve Corrective/Preventative actions addressing Quality, Technical, and Manufacturing issues.
* Project Management: Plan accurately, deliver timely, and report on project deliverables. Participate in risk assessments and HAZOPs of manufacturing processes and equipment.
* Establish and maintain Behavioural Standards aligned with company standards and policy.
* All employees are responsible for Environmental and Health & Safety impacts of their work. Stay updated on new technologies and present Best Practice methodologies, procedures, and equipment to the company proactively.
Education and Experience
* A Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical engineering is required, along with minimum 4 years' experience. Relevant experience with statistical process control and capability analysis is essential.
* Six Sigma/Green Belt/Black Belt accreditation would be highly advantageous.
* Excellent analytical and problem-solving skills, root cause analysis, and risk assessments with a strong attention to detail are necessary.
* Familiarity with manufacturing and validation in a regulated environment (FDA or IMB) is an advantage.