Job Title
An exciting opportunity exists with an award-winning Medical Device organization based in Limerick.
Duties
* Develop and execute plans to continuously improve and optimize product quality and process yield, utilizing process characterization, optimization, problem solving, and decision-making tools.
* Identify and implement process-related continuous improvement activities to enhance 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 work ethos within the team, engaging with personnel to address Quality, Technical, and Manufacturing issues.
* Project Management: Plan, deliver, and report project outcomes accurately and on time, participating in risk assessments and HAZOPs of manufacturing processes and equipment.
* Maintain Behavioural Standards aligned with company policy.
* Adhere to Environmental and Health & Safety protocols, staying updated on new developments and technologies in assigned disciplines, and presenting Best Practice methodologies to the company.
Education & Experience
* Hold a Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical engineering, with a minimum of 4 years' experience and relevant knowledge of statistical process control and capability analysis.
* Six Sigma/Green Belt/Black Belt accreditation is advantageous.
* Possess 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 environment is an advantage.