Keisha Monique

• Lead complaint investigations assessing reportability, compliance, patient safety impact, and product quality risk.
• Establish regulatory reporting decisions using hazard analyses, DFMEAs, investigation evidence, and decision models.
• Apply complaint coding to strengthen product performance trending and post-market surveillance visibility.

• Triaged product quality events for reportability under 21 CFR Part 803, 21 CFR Part 820, EU MDR, and internal procedures.
• Generated complaint decision trees supporting MDR determinations and regulatory submissions to FDA, EU, PMDA, and global authorities.
• Analyzed device performance, complaint history, clinical documentation, manufacturing records, and investigation data during remediation

• Investigated and peer reviewed customer grievances for Class II pre-filled syringe combination products and biologic drug vial complaints.
• Evaluated CAPA, SCAR, deviations, change controls, and NOEs to identify potential contributing factors.
• Reviewed CMO batch records, Certificates of Analysis, technical documents, and LIMS retention evidence for conclusions.

• Created and managed complaint records in TrackWise 8.7 and 10.0 for incoming RDU device and biologic issues.
• Generated pivot tables and bar graphs summarizing complaint outcomes for executive, senior management, and product safety review.
• Escalated OOS and OOT investigation findings from batch record reviews during weekly departmental meetings.

• Reduced complaint investigation backlog for Class II prefilled syringe combination product complaints.
• Processed Device Engineering Investigations in TrackWise for complaint review and closure.
• Maintained quality, procedural compliance, and timeline adherence while completing daily complaint workload.

• Owned complaint investigations and remediation for ECG systems, patient monitors, PIC iX software, ventilators, and respiratory products.
• Investigated customer complaints involving device hardware, PCBAs, electronic components, and system-level failures.
• Prepared TrackWise investigation summaries using technical findings and service reports from Salesforce and SAP.

• Conducted complaint investigations for BACT/ALERT microbial detection systems and PCBA electronic component failures.
• Evaluated device performance data, manufacturing records, product history, and failure trends to determine complaint impact.
• Documented complaint investigations, nonconformances, quality events, outcomes, and regulatory records in TrackWise.

• Documented TrackWise investigations for Class II and III devices across Peripheral Intervention, Interventional Radiology, Critical Care, and Endoscopy.
• Used DHF, DHR, DMR, MBR, and nonconformance reports to support complaint investigation conclusions.
• Drafted Quality Engineering Risk Assessments for Senior Management and Regulatory Affairs approval.

• Managed technical complaint investigations for PCBAs and electronic components within Personal Diabetes Manager products.
• Reviewed complaint data, manufacturing documentation, device history, and investigation results to identify failure modes.
• Drafted, reviewed, and electronically submitted MDRs through the FDA Electronic Submissions Gateway.

• Remediated adverse event product complaints involving Class I and II hysteroscopic, laparoscopic, and endoscopic devices.
• Investigated and remediated high-volume complaints using Pilgrim Quality Management System.
• Peer reviewed and submitted MDRs for malfunctions, adverse events, serious injuries, and death reports.

• Served as Lead Complaint Investigator for the Service and Repair business unit.
• Performed triage, intake, and investigations for Class I, II, and III devices through ETQ and CatsWeb QMS.
• Monitored complaint and MDR progress to ensure documentation completeness, supplemental submissions, and timely closure.

• Coordinated intake of complaints for parenteral drugs and Class II medical devices through TrackWise.
• Performed batch record reviews and escalated investigations requiring Subject Matter Expert evaluation.
• Participated in training programs for plant quality and manufacturing personnel on Sampling and Process Control.

• Served as SAP Super User coaching manufacturing and packaging staff during software implementation.
• Performed batch record reviews supporting quality documentation and product release readiness.
• Completed AQL Sampling for defective products to support lot release, inspection, or rejection decisions.

Grade: 3.3