Job Title
We are seeking a skilled Professional for an exciting opportunity with an award-winning Medical Device organization based in Limerick.
This is an excellent position for anyone looking to join a leading multinational who excel in their field.
Duties and Responsibilities
* The successful candidate will be responsible for the development and execution of plans to continuously improve and optimize product quality and process yield.
* Identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
* Ensuring all process developments and improvements meet the Quality Management System requirements (ISO 13485, FDA & JPAL).
* Leading by example and demonstrating strong leadership within the team.
* Engaging with personnel to identify and resolve Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues.
* Project Management: Accurate planning, timely delivery and reporting for all project deliverables.
* Participating in risk assessments and HAZOPs of manufacturing processes and equipment.
* Developing and maintaining Behavioural Standards in line with company standards and policy.
* Maintaining awareness of new developments and technologies in assigned disciplines and presenting Best Practice methodologies, procedures, processes and equipment to the company.
Requirements
* 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.
* 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.