Summary
Overview
Work History
Education
Skills
Timeline
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PRAVALLIKA MEDABALIMI

New Bedford

Summary

Detail-oriented Quality Engineer with over 5 years of experience in quality inspection, regulatory compliance, and quality system management in healthcare and medical device environments. Skilled in visual and dimensional inspection, root cause analysis, documentation, and use of precision tools such as calipers and micrometers. Strong understanding of ISO 13485, GMP, and CAPA processes. Passionate about maintaining product quality, supporting production teams, and ensuring compliance through effective QA practices.

Overview

7
7
years of professional experience

Work History

Biomedical Engineer

ICS Global Soft Inc
08.2024 - Current
  • Conducted visual inspections to identify defects in production materials and finished products.
  • Ensured compliance with quality standards through meticulous documentation and reporting processes.
  • Collaborated with production teams to address quality issues and implement corrective actions promptly.
  • Operated measurement tools effectively to assess product dimensions and tolerances.
  • Collaborated with manufacturing team to ensure consistent quality standards across all products.
  • Lead in-process and final quality checks to ensure product conformance to engineering drawings and regulatory standards.
  • Provide engineering support in process validation, risk analysis, and equipment qualification activities.

Systems and Quality Engineer

Appminds Technology Services
08.2018 - 01.2022
  • Performed incoming, in-process, and final inspections of medical device components and assemblies.
  • Used measurement tools including calipers and micrometers to verify product dimensions and tolerances.
  • Managed and maintained QMS documentation in compliance with ISO 13485 and GMP regulations.
  • Conducted root cause analysis and supported CAPA implementation for nonconforming products.
  • Automated reporting using SQL and Power BI, enhancing traceability and reducing manual entry errors.
  • Collaborated with cross-functional teams to support device validation and regulatory submissions.
  • Participated in internal audits and prepared documentation for external quality assessments.
  • Perform visual and dimensional inspections of biomedical components and devices using precision tools such as calipers, micrometers, and height gauges.

Education

Master of Science - Biomedical Engineering And Biotechnology

University of Massachusetts, Dartmouth
North Dartmouth, MA
05-2024

Bachelor of Science - Biotechnology

Koneru Lakshmaiah University
India
05-2018

Skills

  • Visual & Dimensional Inspection (Calipers, Micrometers, Height Gauges)
  • ISO 13485, GMP & FDA Compliance
  • Root Cause Analysis & CAPA
  • First Article Inspection Reports
  • Gage Control & Calibration Management
  • Blueprint & Technical Drawing Interpretation
  • QMS Documentation & Internal Auditing
  • Python, SQL, Power BI (for Quality Data Analysis)
  • Lean Six Sigma & FMEA
  • Medical Device Testing & Validation

Timeline

Biomedical Engineer

ICS Global Soft Inc
08.2024 - Current

Systems and Quality Engineer

Appminds Technology Services
08.2018 - 01.2022

Master of Science - Biomedical Engineering And Biotechnology

University of Massachusetts, Dartmouth

Bachelor of Science - Biotechnology

Koneru Lakshmaiah University

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PRAVALLIKA MEDABALIMI