Open To Work
Swati Patel
Austin
Summary
Results-oriented quality assurance professional with 17 years in managing QA teams and implementing processes across manufacturing, power electronics, IT, aerospace, and healthcare. Expertise in ISO standards and regulatory compliance, with a strong focus on audits, process optimization, and cross-functional collaboration. Seeking a Quality Assurance Manager role to drive operational efficiency and ensure compliance.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
eInfochips
Ahmedabad
2010.09 - 2023.07
- Led a quality assurance team of [6-10] members to ensure compliance with ISO 13485, AS9100, ISO 9001, and FDA regulations
- Implemented and managed QMS processes to improve product quality and regulatory compliance
- Conducted internal, supplier, and process audits to uphold high standards and pinpoint areas for improvement
- Developed and maintained quality management systems for manufacturing, embedded design, software design life cycle (SDLC), and ASIC projects to ensure regulatory compliance
- Collaborated with cross-functional teams to support product development and process optimization
- Maintained liaison with external certification bodies and ensured the effective implementation of all external audits throughout the organization
- Monitor quality performance metrics and drive continuous improvement initiatives
- Identify quality risks and implement corrective and preventive actions
- Lead root cause analysis for nonconformities and customer complaints
- Support management reviews by preparing quality performance reports and recommendations
- Ensure supplier quality management through evaluations, audits, and performance monitoring.
- Promoted culture of quality, compliance, and continuous improvement across organization.
Senior Quality Engineer
Amtech electronics
Gandhinagar
2005.12 - 2010.09
- Facilitated ISO 9001 implementation and quality management systems in manufacturing operations within Power Electronics sector
- Performed product, process, and supplier audits to ensure compliance with industry standards
- Performed quality inspections of products to meet regulatory standards such as UL514 for PCBs, panels, switchgears, and variable frequency drives
- Conducted root cause analysis and recommended corrective actions for quality issues
- Conducted training for staff on quality procedures and regulatory requirements to ensure compliance
- Collaborated with engineering and production teams to drive continuous improvement initiatives
Education
Bachelor of Engineering - Electronics and Communications Engineering
Atmiya University
Gujarat2005-07
Skills
- Regulatory auditing
- ISO 9001, ISO 27001, ISO 13485, AS9100D
- CMMI and compliance frameworks
- Data privacy regulations
- Regulatory compliance
- Quality management
- Embedded design
- Software lifecycle
- Agile methodology
- Cybersecurity and risk assessment
- Supplier audits
- Root cause analysis
- Stakeholder management
- Data analysis
- Statistical analysis
- Quality assurance
- Agile Scrum methodology
- Hardware and embedded design
- ASIC design and verification
- Supplier evaluation
- Customer relationship management
- Cross-functional collaboration
- Cross-functional teamwork
- Hardware and embedded design
- Communication skills and data analysis
- Employee training
- Performance measurement
- Audit management
Certification
- HealthCare, ISO 13485: 2016 Internal Auditor, 08/16, DNV-GL, Medical device software demonstrating compliance to IEC62304, 02/16, UL India, Overview of 21CFR820 Quality System Regulation for medical devices, 02/16, UL India, HIPAA, 02/21, Udemy
- Aerospace, AS9100D Internal Auditor, 06/17, DNV-GL, DO 254 and ARP4754A, 04/14, Ferrell and Associates Consulting Inc.
- Automotive, Introduction to Automotive SPICE V3.1 (VDA) and Internal Auditor training, 10/19, IQI
- Information/Cyber Security, Internal Auditor of Information Security Management System (ISO27001:2013), 04/21, Bureau Veritas, Cybersecurity Awareness, 01/22, Simplilearn, Certified Information Systems Auditor (CISA), 06/23, Simplilearn, Advanced Executive Program in Cybersecurity, 08/25, IIIT-B, Simplilearn
- QMS, ISO9001:2015 Internal Auditor, 05/16, Bureau Veritas, CMMI-DEV V1.3 Level-3 Introductory and ATM training, 10/16, QAI, Lean Six Sigma Green Belt, 05/20, TUV SUD, Mastering Agile Scrum, 10/15, QAI, Root Cause Analysis, Year 2011, DNV, GDPR, 03/21, Udemy
Accomplishments
Received various awards and recognitions for the best performance like Core value Award, Rock Award, Jack of the Box Award, Pet on the Back etc.
Languages
English, Fluent
Work Preference
Job Search Status
Open to workWork Type
Full TimeContract WorkLocation Preference
RemoteOn-SiteHybridSalary Range
$45000/yr - $200000/yrTimeline
Quality Assurance Manager
eInfochips
2010.09 - 2023.07
Senior Quality Engineer
Amtech electronics
2005.12 - 2010.09
Bachelor of Engineering - Electronics and Communications Engineering
Atmiya University