Head of Quality Department. Led team of 5 QC Technicians.Led Validation Program including Sterilization (EtO and Gamma Radiation), Equipment, and Packaging Validations.Owned NC-CAPA program which focused on creating a culture of continuous improvement.Implemented an eQMS software to streamline QMS and improve product quality and safety.Led Management Review activities.Main auditee during external and internal quality audits. Created corrective action plans in response to audit nonconformances.Implemented and validated label software and created labels in compliance with MDR requirements.Reviewed DHRs, Calibration Reports, SLARs, and Document Change Requests.Communicated monthly Key Performance Indicators (KPIs) to executive management.

Act as consolidation point for receiving, processing, investigating and reporting product complaints for implantable lenses (Class III medical device). Interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements. Ensure Medical Device Reports and Vigilance reports are submitted in compliance with U.S. FDA Regulations, and Canadian Medical Device Regulations. Utilize the Corrective Action/Preventive Action process, when appropriate, as a result of complaint investigation, managing an MDR or complaint trend. Participate in external (FDA, ISO) and internal audits as required