The Quality Assurance Manager is a pivotal member of the plant’s quality team, responsible for ensuring adherence to internal and external quality standards throughout the production process.
Key responsibilities include, but are not limited to
:Conducting comprehensive reviews of the plant's Management System to verify compliance with regulatory and company requirements
.Overseeing and administering Change Controls (Methods of Change) to identify, evaluate, and document process adjustments
.Investigating, documenting, and resolving Deviations from standard operating procedures to maintain product and process integrity
.Leading and managing Quality CAPAs (Corrective and Preventive Actions), ensuring proper root cause analysis and timely closure
.Handling all Non-Conformance events, including root cause identification, investigation, documentation, and implementation of corrective actions
.Managing the complaints process from initial receipt, through investigation, and to resolution, maintaining accurate records throughout
.Supporting, preparing for, and participating in internal and external audits; compiling audit responses and corrective action plans as needed
.Assessing and authorizing product disposition, ensuring only materials meeting quality standards are released for use or shipment
.Collaborating with cross-functional teams (Production, Engineering, Regulatory, EHS) to drive continuous improvement and ensure compliance
.Maintaining accurate, up-to-date documentation and reports in alignment with company and regulatory policies