Support and maintain the Quality Management System to ensure compliance with medical device regulations (ISO 13485, 21 CFR 820, MDSAP). Assist QMS procedure implementation, internal audits, CAPA facilitation, complaint handling, document review, QMS metrics and reporting, and cross-functional health hazard evaluations to support regulatory compliance and product introductions.

Provide on‑the‑floor QA oversight for biopharma manufacturing: review batch records, perform line clearance, support QC activities, approve shipments, manage deviations/CAPAs/change controls/investigations/holds, support regulatory inspections, ensure GMP compliance, and maintain document control and procedures.