Quality Specialist

• 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.

• 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.

• 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.

• 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.

Sigmar Recruitment