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