Job Description
We are seeking a highly skilled Quality Engineer to join our Precision Engineering Facility in Shannon, Clare on a permanent contract.
Key Responsibilities
* Perform Design History File (DHF) reviews to facilitate timely product release.
* Ensure adherence to relevant regulations, including FDA and ISO standards.
* Promote customer requirements awareness across the organization.
* Collaborate with production teams to determine product disposition.
* Support quality processes by embedding quality into Specialized Life Ending (SLE) products and ensuring regulatory compliance.
* Oversee and execute Quality Management System (QMS) activities, including non-conformance investigations, Corrective Action Preventive Action (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.
Requirements
* A minimum of 2 years' experience in a Quality Assurance role in Medical Device or Pharma is preferred.
* Excellent verbal and written communication skills.
* Working knowledge and understanding of Quality System Regulation (QSR) and ISO quality system requirements.
About Us
Our client primarily contracts manufacture and offers precision engineering solutions to top Medical Device companies in Ireland.