Overview

The primary function of this role is to provide technical leadership within Supplier Quality Engineering and to support to 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

Department: Supplier Quality Engineering
Drive all assigned Supplier Quality Engineering projects and ensuring 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 team at key review meetings.
Work closely to 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 using the Quality Engineering Manager as the final arbitrator on critical quality decisions.
Identify and implement opportunities for improvement and implements under their 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 management of the supplier corrective action process. Maintain and update 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 (KPI’s) and participate in supplier performance reviews. Completion and approval of supplier evaluations and monitoring when required.
Manage and drive continuous improvement activities focusing on supplier quality.
Review and support Supplier Change Notifications.
Review and approval of raw materials, first part approval and supplier process validations.
Maintaining 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 CAPA’s.
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

Department: Supplier Quality Engineering
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

#LI-Hybrid

Senior Quality Engineer (Supplier)

Benefits

Job Description