Quality assurance specialist

QA Validation Engineer Role

We are seeking a skilled QA engineer to join our team at an innovative medical device manufacturer in Ireland.

This is an excellent opportunity for a motivated individual with experience in quality/validation engineering to take on new challenges and contribute to the success of our manufacturing site.

* Coordinate and participate in validation and quality assurance activities for site equipment, utilities, processes, and software, ensuring compliance with FDA, European cGMP, and GAMP standards.
* Develop and maintain Site Validation Master Plans, Project Validation Plans, and schedules.
* Create and review validation protocols, final reports, and investigation documents, ensuring adherence to cGMP standards.
* Manage validation, exception event, and change control processes, maintaining accurate records and documentation.
* Perform cross-training and train new team members to ensure continuous improvement and knowledge sharing.
* Degree in engineering or scientific discipline.
* Three years or more of validation/QA experience in medical device plastics processing, moulding, or assembly operations.
* Three years or more of knowledge of cGMP and regulatory requirements relating to the medical device industry.
* Proficiency in Validation Quality Assurance GMP Regulations GAMP.