• Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Software Validation, Microbiological and Sterilisation assessments and Critical System Work Orders.
• Provide Quality Engineering support to the Research and Development, New Product Introduction (NPI) and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Inputs, Design Verification/Design
• Validation, Design and Product transfer, Design and Process FMEA and Process Validation.
• Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
• Drive the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
• Drive field action assessments and support field action.
• Support of the Internal Audit and Regulatory Audit Programmes. Represent Quality Engineering in audits.
• Analyse quality data to identify trends, highlight systemic risk, and drive improvement actions
• Initiate, manage and execute projects for continuous improvement within the department.
• Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Provides informal mentoring and technical guidance to QE1s.
• Delegate to the Senior Quality Engineer/ Quality Engineering Team Lead.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Minimum of 3 years experience in a quality engineering role or related technical discipline.
• Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
• Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
• Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation.
• Good working knowledge of statistics.
• Experience in combination devices would be an advantage.
• Strong interpersonal skill with the ability to communicate effectively at all organisational levels.
• The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical
• Quality Systems and Processes are adhered to.
• The ability to make independent, risk based quality decisions within QMS and regulatory frameworks.
• High attention to detail in all aspects of the role.
• Excellent organisational skills.
• Proven problem-solving skills.
• High self motivation.
• Good working knowledge of Microsoft Office.
• Willingness and availability to travel on company business.

About Cook Limerick

Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets.

Our employee benefits include:

• Hybrid Work Model
• Company sponsored Defined Contribution pension scheme
• Medical Health Insurance cover for you and your immediate family
• Life Assurance and Income Protection cover
• Educational Assistance
• Performance related Bonus
• Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
• Fully equipped gym on site
• 39-hour week with flexible start & finish times
• Paid time off to participate in volunteer activities
• Free parking
• Subsidised restaurant
• Sports & Social club