We are looking for a Quality Engineer to join a Precision Engineering Facility based in Shannon, Clare on a permanent contract. Our client primarily contract manufactures and offers precision engineering solutions to top Medical Device companies in Ireland.
Quality Engineer's Responsibilities:
Perform DHR reviews to facilitate the timely release of products.
Ensure adherence to relevant regulations (e.g., FDA, ISO standards).
Promote awareness of customer requirements across the organization.
Collaborate with production teams to determine product disposition.
Support production processes by embedding quality into SLE products and ensuring regulatory compliance.
Oversee and execute Quality Management System (QMS) activities, including non-conformance investigations, CAPA, change control, complaints, document control, and record retention.
Design, implement, and sustain procedures and associated forms.
Lead and manage quality system upgrades and improvements.
Participate in internal and external audit processes.
Support customer and regulatory audit preparations and responses.
An ideal Quality Engineer will have:
2+ years in a Quality Assurance role in Medical Device or Pharma is preferred.
Excellent verbal and written communication skills
Working knowledge and understanding of QSR and ISO quality system requirements
For a confidential discussion and more information on the role, please contact Alicja Burchardt.
alicja.burchardt@collinsmcnicholas.ie
0212427109