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Quality Control Manager

Quality Control Manager

BacteromicWarszawa, Województwo mazowieckie, Polska
19 days ago
Job description

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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Quality Manager • Warszawa, Województwo mazowieckie, Polska

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