Overview:
The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Facilities, IT, Regulatory, Analytical Lab, Research and Development, New Product Introduction and Engineering Sustaining and Post Market teams. This includes, but is not limited to, providing support to design and process validation, change requests, nonconforming product issues, Corrective and Preventive Action program, risk management, trending analysis, audit support, microbiology and sterilisation review and associated Quality System Documentation.
Responsibilities:
- Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Software Validation, Microbiological and Sterilisation assessments and Critical System Work Orders.
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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
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Validation, Design and Product transfer, Design and Process FMEA and Process Validation.
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Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
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Drive the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
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Drive field action assessments and support field action.
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Support of the Internal Audit and Regulatory Audit Programmes. Represent Quality Engineering in audits.
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Analyse quality data to identify trends, highlight systemic risk, and drive improvement actions
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Initiate, manage and execute projects for continuous improvement within the department.
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Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
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Provides informal mentoring and technical guidance to QE1s.
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Delegate to the Senior Quality Engineer/ Quality Engineering Team Lead.
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Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications:
- Third Level qualification in Science, Engineering or a relevant technical discipline.
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Minimum of 3 years experience in a quality engineering role or related technical discipline.
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Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
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Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
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Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation.
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Good working knowledge of statistics.
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Experience in combination devices would be an advantage.
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Strong interpersonal skill with the ability to communicate effectively at all organisational levels.
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The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical
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Quality Systems and Processes are adhered to.
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The ability to make independent, risk based quality decisions within QMS and regulatory frameworks.
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High attention to detail in all aspects of the role.
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Excellent organisational skills.
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Proven problem-solving skills.
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High self motivation.
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Good working knowledge of Microsoft Office.
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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.
Quality Engineering in Limerick
Our QE team in Limerick is made up of 4 different subgroups: quality engineering, supplier engineering, regulatory communications and complaint investigations.
The quality engineering team are responsible for the CAPA, NCR, NC trending and field action assessments processes. They work cross functionality with operations, engineering, medical affairs and regulatory affairs during the design process and throughout the device lifecycle. They are heavily involved in supporting strategic objectives for the site including IT solutions and continuous improvement efforts.
The supplier quality engineering team are responsible for the qualification, auditing, monitoring and assessment of all new and existing suppliers across this site. This ranges from quality impacting suppliers to non-quality impacting suppliers.
The regulatory communications team are responsible for the regulatory assessment and submitting reports as required for all our device customer complaints. In addition, they are responsible for any field actions which are initiated associated with Cook Ireland manufactured devices as well as monitoring and implementing changes associated with regulatory intelligence and are a key input into the post market surveillance programme.
The complaint investigations team are responsible for the root cause, evaluation, investigation, risk assessment and corrective action determination of all our device related customer complaints. They are responsible for the evaluation of any returned medical devices from the field in a biohazard laboratory. The complaint investigation team are also responsible for trending assessments and are a key input into the post market surveillance programme.
Even though these teams are distinctively different in terms of roles and responsibilities, they are all intertwined as they are responsible for different aspects of the product lifecycle which ultimately all feed into one another. Our Quality Engineering team are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.
Our employee benefits include:
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Hybrid Work Model
- Company sponsored Defined Contribution pension scheme
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Medical Health Insurance cover for you and your immediate family
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Life Assurance and Income Protection cover
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Educational Assistance
- Performance related Bonus
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Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
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Fully equipped gym on site
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39-hour week with flexible start & finish times
- Paid time off to participate in volunteer activities
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Free parking
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Subsidised restaurant
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Sports & Social club
#LI-Hybrid #LI-AK1
