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
Scarborough05-2020
Bachelor’s in Engineering - Biomedical Engineering
Mumbai University
Mumbai, India08-2017
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