Summary
Overview
Work History
Education
Skills
Timeline
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Pranay Raj Kandagatla

Denton,Texas

Summary

Qualified Quality Engineer accustomed to developing and monitoring improved inspection strategy to reduce errors and cultivate consistent quality. Dedicated and energetic with proven history of implementing corrective actions to drive quality and improve efficiency. Detail-oriented and motivated Quality Engineer with 4 years of extensive experience in the medical device industry, focused on product quality, regulatory compliance, and continuous improvement initiatives. Proficient in managing CAPA processes, conducting thorough root cause analysis, and ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. Experienced in working with orthopedic implants, diagnostic devices, and women’s health products, ensuring product safety and quality across all stages of production. Adept at managing non-conformance issues and driving supplier quality improvements through SCAR initiatives. Seeking to apply a strong technical and analytical skill set to contribute to a dynamic quality assurance team in a regulated manufacturing environment.

Overview

4
4
years of professional experience

Work History

Quality Engineer

Zimmer Biomet
Tampa, FL
07.2024 - 09.2024
  • Worked on products such as joint reconstruction implants, trauma devices, sports medicine solutions, and robotic surgery systems to ensure compliance with FDA 21 CFR Part 820 and ISO 13485 regulations.
  • Led CAPA investigations for critical products like hip and knee implants, identifying root causes of non-conformities and implementing corrective actions, resulting in a 15% reduction in non-conformance issues.
  • Spearheaded root cause analysis (RCA) for recurring quality issues in orthopedic implant production, improving process efficiency and reducing defect rates across multiple product lines.
  • Managed Supplier Corrective Action Requests (SCAR) for suppliers of surgical instruments and power tools, improving supplier compliance and reducing defect rates by 10%.
  • Supported internal and external audits, ensuring compliance with 21 CFR Part 820 and ISO 13485 for robotic-assisted surgery devices and neurosurgical tools.
  • Collaborated with cross-functional teams, including production, R&D, and supply chain, to drive quality improvements in orthopedic surgical instruments and spinal solutions.

Quality Engineer

Hologic
Danbury, CT
06.2020 - 06.2022
  • Worked on products including breast imaging systems (mammography, tomosynthesis) and cervical cancer screening tools (Pap tests, ThinPrep® solutions), ensuring product quality and regulatory compliance.
  • Played a key role in CAPA investigations for Hologic’s GYN surgical solutions and skeletal health products, driving improvements in device reliability and safety.
  • Managed non-conformance reports (NCR) and corrective actions for in vitro diagnostic (IVD) products used in cervical cancer screening and molecular diagnostic platforms, ensuring quick resolutions and compliance with FDA and ISO 13485 standards.
  • Conducted root cause analysis on product deviations for breast biopsy solutions, identifying potential process failures and implementing corrective actions to improve product performance.
  • Supported Supplier Corrective Action Requests (SCAR) related to diagnostic devices, improving supplier performance and ensuring adherence to ISO 13485 and FDA standards.
  • Assisted in preparing the company for external audits, ensuring all product lines complied with FDA’s 21 CFR Part 820 regulations and ISO standards.
  • Contributed to the development and revision of quality management documentation and SOPs for products used in women’s health diagnostics and breast health solutions.

Education

Master of Science - Information Science

University of North Texas
Denton, TX
05-2023

Bachelor of Science -

NTR University
India
01-2019

Skills

  • Documentation And Reporting
  • Project requirement evaluation
  • Quantitative Analysis
  • Issue Resolution
  • Failure Investigation and Analysis
  • Project Scheduling
  • CAPA (Corrective and Preventive Actions) Management
  • FDA Regulations (21 CFR Part 820)
  • Root Cause Analysis (RCA)
  • ISO 13485 Compliance
  • Non-Conformance Reporting (NCR)
  • Supplier Corrective Action Requests (SCAR)
  • Internal and External Audits
  • Risk Assessments & Mitigation
  • Process Improvement & Lean Manufacturing

Timeline

Quality Engineer

Zimmer Biomet
07.2024 - 09.2024

Quality Engineer

Hologic
06.2020 - 06.2022

Master of Science - Information Science

University of North Texas

Bachelor of Science -

NTR University
Pranay Raj Kandagatla