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 13485 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 14971 principles.
- Strong decision-making, self-motivated, able to prioritize.
- Solid knowledge of the medical device industry.
For a confidential discussion and more information on the role contact Courtney Russell.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
