Your responsibilities :
Lead a multidisciplinary QC team that bridges R&D / development with operational QC, owning the lifecycle from method and product development / verification to manufacturing control and release.
Build and coach the QC team (including suppliers / contract labs) and cultivate a science-driven, data-first culture.
Set QC strategy for new assays, microfluidic cartridges, reagents, and instruments : define method requirements with R&D and plan feasibility.
Own the method lifecycle : development, optimization, validation / verification, tech transfer (often external), change control, and ongoing performance monitoring (trending).
Partner with R&D, QA, RA on risk management (ISO 14971), DOE, tolerance / CTQ flow-down, and readiness criteria for pilot → scale-up.
Direct nonconformity / claims, CAPA, RCA (8D); lead MRB and supplier quality improvements.
Ensure end-to-end traceability, data integrity (ALCOA+), inspection-ready documentation, and compliance with IVDR, FDA QSR.
Inspiring leadership across multidisciplinary teams; clear priorities, rapid escalation, crisp decisions.
Strong scientific rigor in analytical / microbiological method development and fit-for-purpose validation.
Our requirements :
5–10 years in QC / QA within biotech / diagnostics / medical devices; proven team leadership and supplier QC.
Degree in life sciences or engineering.
Hands-on in manufacturing / product quality and continuous improvement across the supply chain.
Practical microbiology (culture, sterility, endotoxin, environmental monitoring).
Working knowledge of IVDR / FDA; strong problem-solving / analytical skills.
Excellent English, written and spoken.
What we offer :
Participate in a unique antibiotic resistance project - We are creating solutions that will realistically protect the health and lives of people around the world,
An atmosphere that fosters open communication and encourages growth,
A job where we combine science, engineering and business - We work with people who inspire, teach and encourage you to achieve ambitious goals.
An international environment - we have 8 nationalities on board
Close collaboration with product, R&D, regulatory, and sales teams.
Benefits
Sharing the costs of sports activities
Private medical care
Remote work opportunities
Flexible working time
Fruits
Integration events
Coffee / tea
Parking space for employees
Quality Manager • Warszawa, Województwo mazowieckie, Polska