Looking for a job

Lupu Andrei

@lupuandrei

Message

Quality Engineer and MedTech regulatory expert blending biostatistics, lab practice, and AI for audit-ready compliance.

Romania

Message

What I'm looking for

AI Product Engineer bridging deep tech and life sciences. I deploy production-ready RAG architectures, cross-domain automations, and data annotation pipelines. Leveraging biostatistical analysis and regulatory mastery (EU MDR/IVDR), I build secure, deterministic, audit-ready systems ensuring absolute data integrity. Seeking remote, impact-driven roles.

I’m a highly analytical Quality Engineer and MedTechRegulatory expert—bridging pharmaceutical manufacturing, advanced laboratory research, clinical data excellence, and complex regulatory compliance (EUMDR / IVDR). I focus on keeping data integrity (100% compliance with GLP and ALCOA+), turning regulatory requirements into audit-ready, traceable deliverables.

As CEO & Co-Founder of Loopal (MedTech Enterprise AI), I engineered deterministic logic for automated EUMDR/IVDR compliance audits, generating Gap Analyses and Traceability Matrices (Annex II & III) with a “zero hallucinations” mindset. I also bring hands-on expertise from quality engineering—recording/archiving lab data under ALCOA+ and GLP, authoring SOPs, and driving CAPA through deviation investigations.

Experience

Work history, roles, and key accomplishments

Current

CEO & Co-Founder

Current

Loopal

Jan 2026 - Present (4 months)

Engineered a deterministic logic framework for Loopal to automate EUMDR/IVDR compliance audits, targeting zero hallucinations. Translated regulatory requirements into algorithmic rulesets to generate gap analyses and traceability matrices (Annex II/III) and led cross-functional alignment across quality and compliance workflows.

EUMDR (2017 745)IVDR (2017 746)Deterministic AI Architecture Gap Analysis Annex II III Mapping

Quality Engineer

Terapia - A Sun Pharma Company

Apr 2025 - Oct 2025 (6 months)

Maintained 100% audit readiness by recording and archiving experimental and laboratory data in line with ALCOA+ principles. Performed GLP-compliant laboratory testing on packaging systems and authored SOPs while investigating deviations and implementing CAPA.

GLP Laboratory Quality Assurance SOP Development CAPA Audit Readiness Laboratory Testing Data Archiving

Education

Degrees, certifications, and relevant coursework

Iuliu Hatieganu Medicine and Pharmacy University (UMF Cluj)

Master's Degree in Biostatistics and Bioinformatics, Biostatistics and Bioinformatics

2025 -

Master's Degree program focused on clinical trial design, statistical modeling (R/Jamovi), and bioinformatics data analysis.

Babes-Bolyai University

Bachelor's Degree in Industrial Biotechnology, Industrial Biotechnology

2018 - 2023

Grade: Thesis score: 10/10

Bachelor's Degree in Industrial Biotechnology with coursework in medical, pharmaceutical, and food biotechnology, genetics, and analytical chemistry, including a thesis on genetic potential of groundwater denitrifying bacteria for bioremediation.