Quality Engineer, Prenatal
Core
Ensure quality and compliance for prenatal and cancer diagnostic lab operations, including LDTs, bioinformatics, and report automation.
Role type
Senior Quality Engineer (LDT/Prenatal Lab Operations)
Builds
Prenatal and cancer diagnostic tests (Unity Complete, Unity Confirm, Northstar)
Domain
Molecular diagnostics / Prenatal screening / Oncology
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
LDT environment expertise, lab practices, bioinformatics, report automation, assays, reagents, quality tools, quality management systems, continuous improvement methodologies, project management
Preferred skills
Lean, Six Sigma, Root Cause Analysis, Design Control, Risk Management, Usability, Software Quality, Agile/Scrum, data visualization (Tableau), electronic QMS (Arena, Medialab)
Technologies
Arena, Medialab, Tableau
Responsibilities
Monitor and maintain lab operations and investigate issues; drive occurrence management (Nonconformances, CAPAs, Deviations, Complaints); develop and monitor QA programs for regulatory compliance (CLIA, CAP, NYSDOH); provide training and mentorship to lab staff and peers; review technical requirements, design specs, and validation protocols; support internal audits and continuous improvement; track quality KPIs and generate metrics reports; maintain compliance with FDA, CLIA, CAP, and ISO requirements.
Seniority
Senior, hands-on IC
