Summary
Overview
Work History
Education
Skills
Timeline
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Vidhi Patel

Brampton,ON

Summary

Detail-oriented Quality Engineer with 4+ years of experience in the medical device industry, focusing on quality assurance, supplier collaboration, regulatory compliance, and continuous improvement. Certified Internal Auditor (ISO 13485:2016) with hands-on experience in root cause analysis, nonconformance management, audits, and documentation control. Recognized for strong follow-through, clear communication, and the ability to work across teams to resolve issues effectively and maintain compliance.

Overview

5
5
years of professional experience

Work History

Quality Engineer

Stryker
09.2025 - Current
  • Assisted in the development and implementation of quality control procedures to enhance operational efficiency.
  • Collaborated with cross-functional teams to identify defects and recommend corrective actions.
  • Supported root cause analysis activities to resolve quality issues effectively and promptly.
  • Investigate product complaints, nonconformances, and quality issues with suppliers and internal teams to ensure timely resolution.
  • Partner with contract manufacturers and suppliers to address quality concerns and support smooth day-to-day operations.
  • Conduct supplier re-assessments, review documentation, and maintain compliance records.
  • Manage engineering change orders (ECOs/PCOs) and contribute to SOP updates to improve clarity and usability.
  • Support internal and external audits (FDA, ISO 13485, MDSAP) by preparing documentation and coordinating logistics.
  • Track and review quality metrics to identify trends and support improvement activities.

QA Specialist

MOLLI Surgical
01.2024 - 09.2024
  • Maintained compliance of the QMS by updating procedures and conducting internal audits.
  • Drafted and revised SOPs to improve process efficiency and collaboration.
  • Investigated nonconforming materials and supported corrective actions with cross-functional input.
  • Assisted with CAPA and change control documentation, ensuring timely closure.
  • Monitored and reported quality data to support management

Quality Engineer

Engineering CPR
02.2022 - 12.2023
  • Performed inspections of incoming materials and components to confirm compliance with specifications.
  • Investigated production and supplier-related quality issues, documenting nonconformances and follow-up actions.
  • Supported product changes and transfers through documentation review (DHRs, work orders, work instructions).
  • Coordinated calibration activities and supported quality planning with production and engineering teams.
  • Conducted internal audits to ISO 13485:2016 and supported external audit readiness.

Manufacturing Electronic Technologist

Engineering CPR
09.2020 - 01.2022
  • Built, calibrated, and tested medical devices, resolving technical and process-related issues.
  • Complied with ISO 13485, GMP, and SOP requirements in daily manufacturing work.
  • Suggested improvements to reduce costs and enhance production efficiency
  • Mentored junior technologists, fostering skill development and knowledge transfer within the team.
  • Coordinated inventory supplies and equipment to maximize team productivity.

Education

Advanced Diploma - Biomedical Engineering

Centennial College
Scarborough
05-2020

Bachelor’s in Engineering - Biomedical Engineering

Mumbai University
Mumbai, India
08-2017

Skills

  • Certified Internal Auditor ISO 13485:2016
  • Nonconformance & Issue Resolution
  • Supplier Collaboration & Documentation Review
  • Change Control & Document Management
  • FDA, ISO 13485, MDSAP Audit Support
  • Quality Metrics Tracking & Reporting
  • Cross-Functional Teamwork Clear Communication

Timeline

Quality Engineer

Stryker
09.2025 - Current

QA Specialist

MOLLI Surgical
01.2024 - 09.2024

Quality Engineer

Engineering CPR
02.2022 - 12.2023

Manufacturing Electronic Technologist

Engineering CPR
09.2020 - 01.2022

Advanced Diploma - Biomedical Engineering

Centennial College

Bachelor’s in Engineering - Biomedical Engineering

Mumbai University
Vidhi Patel