Excellent opportunity for a Quality Specialist to join an innovative Medical Devices company based in Sligo. The Quality Specialist will work closely with CMO’s to ensure ISO13485 and IVDR requirements are being adhered to. Experience with lateral flow technology and ISO13485 will be a bonus.
Overview of your responsibilities (full job description available on request)
- Maintain and update the QMS in line with ISO 13485 and IVDR requirements.
- Manage CMO and supplier quality performance, including audits and SCARs.
- Review and approve batch records prior to product release.
- Lead deviation investigations and manage CAPA implementation.
- Review and approve validation protocols (IQ/OQ/PQ) for products and processes.
- Support regulatory compliance, technical documentation, and external audits.
Knowledge, Skills and Experience Required for the Role:
- Level 7/8 degree in Life Sciences or Engineering.
- 3–5+ years’ QA experience in a regulated industry (IVD, Medical Device, or Pharma).
- Knowledge of lateral flow technology and diagnostic reader validation (IEC 62304).
- Working knowledge of ISO 13485 and ISO 14971.
- Strong communication, technical writing, and attention to detail.
- Team player with ability to influence external partners/CMOs.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
