Excellent opportunity for a Quality Engineer to join a Medical Devices Leader in the North West of Ireland. The Quality Engineer will manage the QMS and will be responsible for reviewing and approving validation deliverables across various areas, including Equipment, Facilities, Utilities, Software, and Analytical validations at the site. The QA Engineer will ensure quality compliance of associated records, procedures, work instructions, and training materials.
Overview of your responsibilities (full job description available on request):
Approve validation deliverables for Equipment, Facilities, Utilities, Software, Spreadsheets, and Analytical validations at the site.
Develop and maintain Quality System procedures.
Ensure the site produces safe, effective products in compliance with customer needs.
Monitor and maintain the quality and compliance status of related records.
Maintain the quality and compliance of associated procedures, work instructions, and training materials.
Present and communicate status, report metrics, and identify trends and improvement initiatives.
Knowledge, Skills and Experience Required for the Role:
Qualification in Engineering, Manufacturing, or Science.
Minimum 2 years of experience in Engineering, Manufacturing, or Scientific roles.
1-2 years of validation experience in manufacturing or Testing Laboratories, with a focus on software and equipment validations.
Desirable: Experience with Manufacturing Execution Systems and manufacturing databases.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062