Senior Engineer - Process Capability & Quality Strategy (H/F)

We are currently looking for a Senior Engineer - Process Capability & Quality Strategy to join the Transfer and Industrialization team (TnOP) within the Manufacturing Operations department. The exciting primary responsibility of this role will be to facilitate the QC harmonization of all LSG-Paris products (machines and reagents), with potential expansion to the QC harmonization of LSG products more broadly. Thus, this position involves data analysis with understanding of the entire system (machines, reagents, consumables), as well as a transversal management of change proposals.

Key Missions

- Manufacturing & QC process improvement for instrument, microfluidic and reagent products
Perform critical reviews of existing manufacturing and QC processes, challenge the capability of the control method (cmc) and propose science-based and data-based process improvements.

- CQA & acceptance criteria redesign
Challenge Critical Quality Attributes and acceptance (CQA) thresholds using first-principles understanding, risk analysis, and empirical evidence.

- Historical data mining & synthesis
Analyze multi-year QC, manufacturing, deviations, and field performance data to establish statistically robust correlations between process parameters, CQAs, and real-world performance.

- Risk-based QC strategy
Implement a modern, risk-based QC framework: focus controls where they add value, remove over-control where risk is low.

- Process capability & variability reduction
In coordination with existing teams of Manufacturing, QC and Industrialization (internal and external), quantify process capability (Cp/Cpk), identify dominant sources of variation, and drive targeted improvements to increase robustness and yield.

-Change management & implementation
Work with the existing teams of Manufacturing, QC and Industrialization (internal and external) to lead the practical deployment of new processes and specifications into production, ensuring smooth transition, minimal disruption, and buy-in from manufacturing and QC teams.

-Documentation & compliance to the Company’s QMS

- Cross-functional technical leadership

- Decision-grade reporting to management.