Quality Specialist
About Your New Employer
- Join an innovative company focused on revolutionizing equine diagnostics with cutting-edge technology.
- Be a key player in a dynamic environment where your expertise directly shapes quality and compliance processes.
- Work alongside passionate professionals dedicated to animal health and regulatory excellence.
About Your New Job
- Establish and maintain the Quality Management System (QMS), with a focus on ISO 13485, IVDR, and medical devices best practices.
- Manage quality relationships with Contract Manufacturing Organization (CMO) partners, oversee supplier quality performance, and conduct external audits to ensure every batch meets the highest regulatory and company standards.
- lead investigations into product non-conformances and customer complaints to ensure effective corrective actions are implemented, and play a key role in reviewing and approving validation protocols for new products.
What Skills You Need
- Degree (Level 7/8) in Life Sciences (Biology, Biochemistry) or Engineering.
- 3+ years of experience in a QA role within a regulated industry (IVD, Medical Device, or Pharma).
- Working knowledge of ISO 13485, ISO 14971, and preferably lateral flow technology and diagnostic software/hardware validation (IEC 62304).
- Meticulous attention to detail, strong technical writing, and the ability to confidently communicate and influence partners and directors.
What's on Offer
- Highly competitive salary: €55,000 TO €65,000
- Opportunity to shape quality processes from the ground up in an agile and impactful role.
- Career growth opportunities in an expanding company specializing in veterinary diagnostics.
What's Next
Apply now by clicking the "Apply Now" button or get in touch to find out more. If this opportunity isn’t quite right but you’re interested in similar roles, we’d love to hear from you!
