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Full-time
bachelor degree
Posted 7d ago
Apply by Aug 5
~40 hrs/week
Responsibilities
The Team Lead will supervise the Quality Engineering group, managing project milestones, compliance, and team performance. They are responsible for overseeing key quality systems including validation, CAPA, and regulatory audit programs.
Requirements
Candidates must hold a third-level qualification in Science, Engineering, or a relevant technical discipline. A minimum of 6 years of experience with medical device regulations such as ISO and FDA is required.
Full job description
Overview
The primary function of this role is to lead and supervise the Quality Engineering group including Senior Quality Engineer(s) and Quality Engineers. Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues. Assess workload for the group and allocate tasks accordingly.
Reporting to: Quality Engineering Manager
Find out more about Cook Medical here
Responsibilities
Drive all assigned 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.
Leading 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.
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.
Responsible for Quality systems including the following key processes within the Quality Engineering group:
Design, Process and Software Validation.
Supplier Quality.
CAPA.
Non conformances.
Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes.
Prepare execute and analyse Quality Engineering Documentation.
Trending and analysis of key Quality metrics.
Responsible for the assessment of risk throughout Quality Engineering key processes and systems.
Provide leadership and mentoring to team members to ensure the effective completion of activities associated with their role.
Designee for the Quality Engineering Manager.
The Quality Engineering Team Leader signature is equivalent to Senior Quality Engineer.
Ensure that Cook’s Code of Conduct is considered with in all business matters carried out on Cook’s behalf.
Qualifications
Third level qualification in Science, Engineering or relevant technical discipline.
Proven knowledge and experience (ideally minimum 6 years) of working with ISO, EU, FDA medical device standard regulations.
Previous supervisory experience would be beneficial.
Excellent communication and inter-personal skills.
Proven track record of perusing continuous self-improvement.
Good working knowledge of Microsoft Office.
Proven Problem-Solving Skills.
Good working knowledge of statistics.
Knowledge and experience of all aspects of validation.
Excellent organisational, time management and presentation skills.
Excellent attention to detail.
Proven self-starter
Willingness and availability to travel on company business.
At Cook, we are building our future on Invention, Connection, People, and Community.
As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.
Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
Offices: 750 N Daniels Way, Bloomington, Indiana 47404, US · 8 Fleming Road, Wan Chai, HK · 300 E Elm St, Canton, IL 61520, US · 1186 Montgomery Ln, Vandergrift, PA 15690, US · O'Halloran Road, Limerick , Munster, IE
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How many Engineering jobs are open in Limerick, Ireland right now?
There are currently 188 open engineering positions in Limerick, Ireland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Limerick, Ireland?
Companies currently hiring include Analog Devices, Regeneron, Johnson & Johnson Innovative Medicine, Verizon, Kirby Group Engineering, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Limerick, Ireland?
Yes — 41 of the 188 open engineering positions offer remote or hybrid work (1 remote, 40 hybrid).
How do I apply for Engineering jobs in Limerick, Ireland?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.