Key Responsibilities

• Review manufacturing and quality documentation and perform final review and disposition of Device History Records, batch records, or lot history records before product release.
• Lead or support investigations of internal, supplier, and product nonconformances; apply structured root-cause analysis; and own assigned CAPAs through effectiveness verification and closure.
• Investigate customer complaints, evaluate returns and quality data, identify recurring failure modes, and support regulatory-reportability assessments when applicable.
• Support incoming, in-process, and final inspection, including visual, dimensional, functional, and analytical evaluation of materials, components, and finished products.
• Interpret inspection and laboratory results and support oversight of calibration, preventive maintenance, out-of-tolerance assessments, and laboratory or inspection systems.
• Review and revise SOPs, work instructions, test methods, forms, and calibration procedures; support ECR/ECO and change-control activities.
• Participate in internal audits and inspections by notified bodies, regulatory authorities, customers, or corporate auditors, including preparation, evidence collection, responses, and follow-up.
• Create quality dashboards and automated workflows using Power BI, Power Automate, Copilot, advanced Excel, or comparable platforms.
• Use approved AI-enabled tools for quality-record categorization, trend identification, document comparison, and investigation summaries, with appropriate verification, human oversight, data integrity, confidentiality, and validation controls.
• Prepare and communicate quality metrics, trends, risks, and escalation items to cross-functional stakeholders and leadership.