Overview
The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, Design and Process FMEA, risk assessment and associated Quality System Documentation.
Reporting to: Team Lead, Quality Engineering
Department: Quality Engineering
Find out more about Cook Medical here
Responsibilities
- Department: Quality Engineering
- Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Test Summaries, Software Validation, Microbiological assessments and Critical System Work Orders.
- Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries.
- Support the Supplier Appraisal and Approval processes.
- Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
- Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
- Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes
- Conducting, documenting and reviewing complaint investigations.
- Risk assessment of customer complaints, Non-conformance and CAPA’s.
- Provide quality engineering support to the Cook Medical Europe quality system.
- Initiate, manage and execute projects for continuous improvement within the department.
- Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
- 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.
Qualifications
- Department: Quality Engineering
- Third Level qualification in Science, Engineering or a relevant technical discipline.
- Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
- Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
- 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.
- 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.
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:
- Company sponsored Defined Contribution pension scheme
- Medical Health Insurance cover for you and your immediate family
- Life Assurance and Income Protection cover
- 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
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