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
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