Quality Specialist
Collins McNicholas View all jobs
- Sligo
- Permanent
- Full-time
- 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.
- 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.