Manages quality systems for medical device products, including CAPA, audits, change control, documentation, field actions, regulatory compliance, and quality metrics. Leads root cause analysis, corrective action planning, audit scheduling and execution, regulatory audit support, standards gap assessments, process improvement projects, and quarterly quality trend reporting. Requires medical device quality assurance experience, lead auditing, regulatory standards knowledge, advanced Excel and PowerPoint skills, and strong technical communication.

Supports manufacturing quality assurance through internal audits, quality-system document control, customer surveys, compliance reporting, calibration management, and control of non-conforming material. Conducts root-cause and corrective-action analysis, coordinates daily RCCA meetings, monitors quality trends, manages customer returns, supports EHS activities, and collaborates with manufacturing, engineering, finance, and external calibration contractors.

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.