Associate Quality Engineer
Core
Support Operations for material receipt, production, process validation, and facility qualification to ensure manufacturing acceptability and compliance.
Role type
Associate Quality Engineer (Manufacturing)
Builds
Production documents, test methods, and validated processes for commercial distribution
Domain
Biotechnology / Medical Devices / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, test method validation, equipment qualification, SOP/WI review, Nonconformance Report management, deviation investigation, audit execution, risk assessment, regulatory compliance (cGMP, ISO, ICH)
Preferred skills
Biotech manufacturing experience, GMP/ISO13485 environment experience
Technologies
None explicitly stated
Responsibilities
Participate in process improvement projects, partner with Operations on production documents and test methods, determine process risks and mitigations, review executed protocols for validation, review equipment calibration records, approve changes to SOPs and WIs, support Nonconformance Reports and Deviations, audit production and support areas
Seniority
Associate, independent execution with periodic supervision
