We have a new Quality Engineer opportunity working for a Medical Devices company in Sligo.
This role will report to the QA Manager and will be responsible for QA Compliance in a clean room manufacturing environment .
The ideal candidate will be dynamic and take their own initiative and have Quality experience in Medical Devices or Pharma/Biotech.
Overview of your responsibilities (full job description available on request): Provide quality support to project teams, production, and clients.
Work with engineering and clients to ensure compliant product specifications.
Review validation plans, protocols, and reports.
Create and maintain product risk management files.
Issue, review, and release lot records for manufacturing.
Coordinate testing and release of sterilized products.
Review SOPs, work instructions, templates, and material specs for compliance.
Review and approve product change controls.
Liaise with suppliers and clients on quality issues.
Support ongoing improvement of the Quality Management System (QMS).
Knowledge, Skills and Experience Required for the Role: Degree in science or engineering.
3–5 years' experience in medical devices.
Strong knowledge of ISO ***** and FDA 21 CFR 820.
Strong understanding of MDR and FDA submissions.
Auditing experience (internal/external) is a plus.
Validation experience (sterilization, process, packaging) is a plus.
Knowledge of cGMP and medical device manufacturing is a plus.
Understanding of ISO ***** principles.
Strong decision-making, self-motivated, able to prioritize.
Solid knowledge of the medical device industry.