Young Innovations, Inc. Benefits Overview

Owns process, equipment, cleaning, and computerized-system validation; calibration and preventive-maintenance programs; monitored systems; and quality documentation. Develops protocols, risk assessments, sampling plans, reports, SOPs, and CAPAs while coordinating cross-functional execution. Maintains compliance with Health Canada GMP and ISO 13485, supports audits, investigates calibration failures and system excursions, trends data, and trains personnel. Requires independent technical judgment in a regulated pharmaceutical and medical-device manufacturing environment.

Provides quality engineering support for FDA-regulated manufacturing, including nonconformance investigations, root-cause analysis, CAPA, risk assessments, validation, quality systems, audits, calibration, and continuous improvement. The role analyzes quality metrics, develops specifications, supports regulatory compliance, evaluates process changes, and collaborates with Quality, Operations, Engineering, and suppliers to improve product and process performance.

Maintain and administer the electronic QMS (QT9), manage controlled document lifecycle, track CAPA/change control/investigation timelines, administer training records, support audits/inspection readiness, and compile QMS metrics. Proactively notify owners of due/overdue items and ensure records are complete and inspection-ready.