MONISHA DAS

Westfield,USA

Summary

Quality and Regulatory Affairs professional with a Master’s degree in Regulatory Affairs and hands-on experience in medical device complaint handling, post-market quality assurance, complaint remediation, CAPA support, and regulatory compliance. Experienced in reviewing and assessing complaint records, identifying potential adverse events, conducting trend analysis, supporting MDR evaluations, and ensuring compliance with FDA 21 CFR Part 820 and ISO 13485 requirements. Proven ability to collaborate with cross-functional teams, manage quality documentation, support post-market surveillance activities, and drive continuous improvement initiatives. Strong analytical, problem-solving, and regulatory knowledge with a background spanning medical devices, quality systems, and healthcare operations.

Diligent [Desired Position] with solid background in ensuring product quality and compliance with industry standards. Proven track record in identifying defects and implementing corrective actions to enhance product reliability. Demonstrated ability in utilizing analytical skills and attention to detail to maintain high-quality benchmarks.

Overview

years of professional experience

Certification

Work History

Quality Assurance Associate

Abbott Laboratories

Westfield, IN

05.2025 - Current

Reviewed quality documentation and complaint records for completeness, accuracy, and compliance with established procedures and Quality Management System (QMS) requirements.
Supported timely closure of quality records by verifying investigation completeness, documentation quality, and adherence to procedural requirements.
Performed data reviews and trend analyses to identify recurring quality issues, process gaps, and opportunities for continuous improvement.
Collaborated with cross-functional teams to support CAPA activities, root cause analysis, remediation tracking, and quality metrics reporting.
Maintained accurate electronic quality records and supported compliance with applicable FDA regulations, internal procedures, and data-integrity expectations.
Escalated potential product-quality and reportability concerns in accordance with established quality-system guidelines.

Inspector Quality Control

EUROFINS

PLANO, TX

09.2024 - 04.2025

Conducted inspections, audits, and testing on materials and products to ensure compliance with quality standards.
Reviewed manufacturing and quality records to ensure adherence to FDA, ISO 13485, and internal procedures.
Identified and documented non-conforming materials and products using quality systems.
Managed disposition and documentation of discrepant materials per approved procedures.
Performed in-process and final inspections to ensure compliance with specifications and standards.
Supported CAPA, deviations, and root cause analysis with inspection data and findings.
Reported audit results, quality metrics, and inspection findings to cross-functional teams.
Maintained inventory accuracy through material handling, tracking, and reconciliation.
Utilized electronic quality systems to ensure data integrity and regulatory compliance.
Verified compliance with manufacturing documentation and quality standards through audits.
Completed inspection records and approvals in compliance with GMP, GDP, and quality systems.
Contributed to continuous improvement initiatives for quality and process enhancement.

Education

Master of Science - Regulatory Affairs

Northeastern University

Boston, MA

Doctor of Pharmacy (Pharm D) - undefined

Dayananda Sagar University

Bengaluru, India

Skills

Quality Systems: Batch Record Review, Batch Release Support, Product Disposition, Deviation Management, CAPA, Change Control, Non-Conformance Management, Root Cause Analysis (5 Whys, Fishbone), Risk Assessment, Quality Event Investigation, Quality Metrics Reporting, Data Integrity Review, Quality Management Systems (QMS)
GMP & Regulatory Compliance: cGMP, GDP, FDA 21 CFR Parts 210/211/820, FDA Part 11, ISO 13485, Aseptic Processing, Cleanroom Operations, Sterile Manufacturing, Environmental Monitoring, Media Fill Documentation Review, Regulatory Compliance
Systems & Applications: SAP, Veeva Vault, TrackWise, eDMS, LIMS, SCADA, BMS, CMMS, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Visio, JMP, Minitab

Documentation & Reporting: SOP Authoring and Review, Work Instructions, Investigation Reports, Batch Documentation Review, Quality Records Management, Technical Writing, Audit Documentation, KPI Reporting, Trend Analysis
Professional Skills: Cross-Functional Collaboration, Communication, Training & Mentoring, Project Management, Time Management, Attention to Detail, Rapid Decision Making, Problem Solving, Continuous Improvement

Certification

ICH GCP by NIDA Clinical Trials Network
Six Sigma Yellow Belt Specialization

ACADEMIC PROJECTS

• SOP Development for Non-Conforming Products – Developed comprehensive SOPs for non-conforming product processes, inspection, and labeling for Class II infusion pumps, ensuring adherence to 21 CFR Part 820, ISO 13485, and quality assurance protocols directly applicable to manufacturing quality environments.

• Comprehensive Regulatory Plan for Tandem Insulin – Developed a regulatory plan addressing pre- and post-marketing needs, enhancing critical thinking to navigate regulatory challenges and ensure compliance with industry requirements for manufactured products.

• Phase 4 Clinical Trial Protocol Development – Designed protocol and identified recruitment locations while executing retention strategies for a Phase 4 clinical trial; conducted thorough FDA guidance reviews to ensure regulatory compliance.

• Regulatory Strategy for SemPresto Autoinjector – Developed a regulatory strategy for an innovative emergency epinephrine auto injector, ensuring safety, efficiency, and FDA approval via the 505(b)(2) pathway.

Timeline