Overview
The primary function of this role is to provide technical leadership within Supplier Quality Engineering and to support the monitoring, approval and appraisal of suppliers from a quality perspective. Provide support and guidance to departments liaising with suppliers from an operations, engineering and quality control perspective. This includes, but is not limited to, providing support to process/ supplier validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, risk assessment and associated Quality System Documentation.
Reporting to: Team Lead, Quality Engineering
Department: Supplier Quality Engineering
Find out more about Cook Medical here
Responsibilities
Drive all assigned Supplier Quality Engineering projects and ensure that they are managed in a structured fashion and completed in compliance with the relevant procedures.
Manage and drive project activities to ensure timely completion of project milestones.
Represent the team at key review meetings.
Build effective relationships with other functions, in particular Operations, IT, Engineering and Regulatory teams.
Lead in the area of FDA, QSR and ISO13485 requirements, promoting awareness of best industry practice and making appropriate decisions on a daily basis with the Quality Engineering Manager as the final arbitrator on critical quality decisions.
Identify and implement opportunities for improvement and implement them under own initiative.
Maintain a proactive approach to developing Cook's Quality system to meet the changing needs of the business.
Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
Perform supplier quality audits and manage the supplier corrective action process. Maintain and update the supplier audit schedule when required.
Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
Track supplier quality performance measurements for suppliers (KPIs) and participate in supplier performance reviews. Complete and approve supplier evaluations and monitoring when required.
Manage and drive continuous improvement activities focusing on supplier quality.
Review and support Supplier Change Notifications.
Review and approve raw materials, first part approval and supplier process validations.
Maintain supplier quality documentation in conjunction with purchasing.
Liaise with Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues.
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.
Completion of risk assessment of suppliers, non-conforming materials and CAPAs.
Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
Designee to the Quality Engineering Team Lead.
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.
Qualification in Quality/Validation/Statistics would be a distinct advantage.
Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
Qualified Lead Auditor, preferably within the Medical Device Industry desirable.
Proven knowledge and experience of all aspects of Validation including Process Validation and design validation.
Good working knowledge of statistics.
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 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.
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:
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
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