LAKSHMI PRIYA MANDA
Gaston,OR
Summary
Quality Assurance Manager leading QMS activities for IVD manufacturing in alignment with ISO 13485, FDA 21 CFR Part 820, and EU IVDR. Manages audits, CAPA, supplier oversight, validation, document control, and product-release records while supporting eQMS migration and compliance with 21 CFR Part 11.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Quality Assurance Manager
Diabetomics, Inc.
06.2025 - Current
- Lead and continuously improve the Quality Management System (QMS) for IVD manufacturing in full alignment with ISO 13485, FDA 21 CFR Part 820, and EU IVDR; establish deep process knowledge by walking the system and mapping components to regulatory standards
- Directly involved in External audits with NSAI and internal audits to evaluate compliance, QMS effectiveness, and adherence to procedures by coordinating documentation, responding to auditor inquiries, driving corrective actions, and ensuring successful audit closure.
- Owned CAPA process, implementing corrective actions and conducting effectiveness checks while ensuring timely closure of NCMRs, SCARs, and deviations in accordance with company procedures.
- Authored SOPs, work instructions, validation protocols and reports (including IQ/OQ/PQ/calibration). Executed end to end change control management including post approval employee training; reviewed and approved quality control forms to support compliant product release.
- Managed technical file documentation, 510k submissions, DHF, DMR, DHR, and risk management files, ensuring comprehensive documentation control and traceability.
- Directed supplier qualification, managing approved critical supplier list and overseeing supplier reevaluation processes.
- Served as the sole project owner for the data migration, system configuration, and validation workflows during a seamless corporate transition from paper-based QMS to eQMS ensuring 21 CFR Part 11 compliance
- IVD medical device manufacturing – ISO 13485 certified environment
Quality Analyst
Solstice Solutions
04.2025 - 06.2025
- Analyzed datasets for reporting, trend identification, and quality improvement activities; monitored supplier performance continuously to minimize nonconformances and drive quality enhancement.
- Investigated customer complaints and nonconforming issues using 5 Whys and Fishbone analysis, implementing corrective and preventive measures that improved response times and issue resolution.
- Supported GMP quality assurance, documentation traceability, and supplier performance monitoring; collaborated with procurement and supply chain teams to resolve quality and compliance issues, enhancing overall supplier reliability.
Validation Engineer
Compleat Technical Sol, Inc.
08.2024 - 04.2025
- Wrote, reviewed validation plans, testing protocols, SOPs, risk assessments, design specifications, and summary reports to support compliant process and equipment qualification.
- Validated documentation to meet regulatory expectations, enhancing audit readiness for quality system processes.
- Conducted deviation investigations and applied root cause analysis to complaints and nonconformances, developing effective corrective and preventive actions (CAPA).
Quality Assurance & Regulatory Affairs
MH. Combiotic, Inc. (Northeastern University Capstone)
01.2024 - 06.2024
- Conducted complaint investigations and CAPA in compliance with 21 CFR Part 111 and ISO 9001 requirements.
- Coordinated supplier qualification, verified Certificates of Analysis against specifications, and maintained quality records, training logs, and compliance checks for audit readiness.
- Executed marketing research on wound care products across USA and Canada; facilitated manufacturing, packaging, and shipping operations while ensuring adherence to quality standards, labeling compliance, and regulatory requirements.
Quality Assurance Associate
Omics Laboratories
, India
05.2019 - 06.2022
- Executed GMP quality assurance activities, ensuring quality records and documentation traceability in regulated manufacturing environment.
- Investigated customer complaints and nonconformances; implemented CAPA through root cause analysis to effectively address issues and prevent recurrence.
- Verified SOP adherence during routine quality assurance checks.
- Reviewed laboratory records and test data at Omics Laboratories for compliance.
- Documented deviations and supported corrective action follow-up.
Education
MS - Regulatory Affairs
Northeastern University
Boston, MA03-2024
Bachelor of Pharmacy -
Andhra University
India05-2022
Skills
- ISO 13485 / FDA 21 CFR 820 / EU IVDR
- QMS Leadership
- Internal & External Audits
- CAPA, Root Cause Analysis & Complaint Investigations
- Continuous improvement
- Supplier Qualification & Oversight
- DHF / DMR / DHR Management
- Validation (IQ/OQ/PQ)
- Document control
- Quality Metrics & Continuous Improvement
- Quality System Training & Employee supervision
- Cross-Functional Team Leadership
- Risk management
Personal Information
Title: QUALITY ASSURANCE MANAGER
Certification
- ASQ Certified Quality Auditor (CQA) — Examination preparation in progress
- 21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices — RAPS
- Understanding and Meeting EU IVDR Requirements for IVD Kits — BSI Training Academy
- ISO 13485:2016 Quality Management Systems for Medical Devices — Alison certification
- ISO 14971:2019 Risk Management — Alison certification
- Person Responsible for Regulatory Compliance (PRRC) — BSI Training Academy
- Introduction to Good Manufacturing Practice (GMP) — Biopharma Institute; additional training in ICH E6, pharmacovigilance, and drug development
- Understanding Periodic Safety Update Reports and how to submit your PSUR — BSI Training Academy
- Demonstrating State of the Art for In Vitro Diagnostic Medical Devices — BSI Training Academy
PUBLICATIONS
- Intellectual Property Rights – A Research Article: International Journal of Drug Regulatory Affairs (Nov 2024 – Mar 2025)
- Comparison of Herbal Drug Regulations in the USA, EU, and India – A Review Article: World Journal of Pharmacy and Pharmaceutical Sciences (Dec 2021 – May 2022)
- PROCESS ANALYTICS FOR PHARMACEUTICAL LYOPHILIZATION: EMERGING TRENDS AND REGULATORY IMPLICATIONS : Next Research – Elsevier (Submitted for Review)
Timeline
Quality Assurance Manager
Diabetomics, Inc.
06.2025 - Current
Quality Analyst
Solstice Solutions
04.2025 - 06.2025
Validation Engineer
Compleat Technical Sol, Inc.
08.2024 - 04.2025
Quality Assurance & Regulatory Affairs
MH. Combiotic, Inc. (Northeastern University Capstone)
01.2024 - 06.2024
Quality Assurance Associate
Omics Laboratories
05.2019 - 06.2022
MS - Regulatory Affairs
Northeastern University
Bachelor of Pharmacy -
Andhra University