Quality Control Manager

6 dni temu

Warszawa, Mazovia, Polska Bacteromic Pełny etat

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

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