Hinal Sanghvi
Santa Barbara,CA
Summary
Dynamic and detail-oriented Quality Assurance Engineer with 3 years of experience in the medical device industry, specializing in quality management systems, regulatory compliance, and process optimization. At True Digital Surgery, I have consistently contributed to the enhancement of product quality and operational efficiency by spearheading root cause analyses, resolving quality issues, and implementing corrective and preventive actions (CAPAs). With a passion for continuous improvement and a deep commitment to patient safety, I thrive in collaborative environments where I can drive improvements in both product and process. Eager to leverage my skills in quality assurance to deliver high-quality, reliable medical devices and contribute to the advancement of healthcare technologies.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Quality Assurance Engineer II
True Digital Surgery
Santa Barbara, CA
06.2024 - Current
- Identify and document non-conformance issues while tracking their resolution, ensuring effective corrective actions are implemented to prevent recurrence.
- Lead the investigation and resolution of quality issues, implementing corrective and preventive actions to address root causes, and enhance product quality.
- Implement ongoing improvement initiatives by revising and enhancing work instructions and production-related documents to ensure processes are optimized for efficiency and compliance.
- Review and process hardware Engineering Change Orders (ECOs), ensuring proper documentation, validation, and traceability of changes to maintain product quality.
- Maintain and update the AVL log, ensuring suppliers meet quality standards, and all vendor-related documentation is current and compliant with company policies.
- Oversee the preparation and verification of shipment paperwork, ensuring timely and accurate documentation for regulatory compliance and customer requirements.
- Provide technical support for any production-related issues, troubleshooting quality problems on the production floor, and collaborating with teams to resolve manufacturing challenges.
- Shadow design activities and collaborate with the design engineering team to ensure quality standards are considered early in the design process and integrated into product development.
Quality Engineer
Nova Eye Medical
Fremont, CA
06.2022 - 02.2024
- Led FDA compliance efforts and secured ISO 13485 certification, increasing organizational efficiency by 20% and reducing non-conformances by 15% through a robust Quality Management System and CAPA initiatives.
- Streamlined document control processes, cutting approval times by 40%, and ensured successful product transfers to Operations by documenting and validating quality measures.
- Managed product feedback and root cause analysis, driving continuous improvement in product quality and customer satisfaction, while enhancing supplier collaboration.
- Spearheaded internal and external audits, ensuring adherence to regulatory standards, and played a key role in aligning product Illumine with evolving MDR requirements.
- Applied Statistical Process Control and DOE methodologies, reducing manufacturing variability and improving product performance, while proactively addressing risk through FMEA and 8D problem-solving techniques.
Healthcare Project Manager
Westlake Convalescent Hospital
Los Angeles, CA
07.2021 - 06.2022
- Led initiatives to improve clinical outcomes and ensure HIPAA compliance during the COVID-19 pandemic, driving significant improvements in clinical performance and reducing compliance gaps.
- Orchestrated internal audits, strategic assessments, and stakeholder communication, facilitating informed decision-making and successful project management despite pandemic challenges.
Continuous Improvement Specialist
Westlake Convalescent Hospital
Los Angeles, CA
06.2020 - 07.2021
- Led process improvements using Six Sigma to enhance efficiency, safety, and compliance across hospital departments during the COVID-19 pandemic, reducing adverse events by 60%.
- Developed training programs to promote continuous improvement, optimizing resource utilization and fostering a culture of learning among staff.
Education
Master of Science - Health Care Administration
California State University, East Bay (CSUEB)
Hayward, CA, USA05.2020
Bachelor of Science - Biomedical Engineering
D. J. Sanghvi College of Engineering
Mumbai, MH, India06.2017
Skills
- Quality Control and Assurance
- FDA Regulation
- ISO 13485
- EU MDR
- CAPA (Corrective and Preventive Action)
- FMEA (Failure Modes and Effects Analysis)
- NCMRs (Non-Conformances)
- Risk Management
- Process Improvement
- Calibration
- Inspection
- ISO Standards
- GMP Requirements
- Design and Development
- Root Cause Analysis
Websites
Certification
- ASQ-Certified Quality Improvement Associate, 01/01/24
- ISO 14971:2019 Risk Management - Medical Device, 01/01/22
- ISO 13485:2016 Requirements - Medical Device QMS, 01/01/22
- ISO 13485:2016 Internal Auditor - Medical Device QMS, 01/01/22
- FDA 21 CFR 820 cGMP Requirements, 01/01/22
- Failure Mode and Effective Analysis, 01/01/22
- ISO 13485:2016 - Design and Development of Medical Device, 01/01/22
- Medical Device Regulation (MDR), 01/01/22
- Project Management Foundations, 01/01/21
References
References available upon request.
Timeline
Quality Assurance Engineer II
True Digital Surgery
06.2024 - Current
Quality Engineer
Nova Eye Medical
06.2022 - 02.2024
Healthcare Project Manager
Westlake Convalescent Hospital
07.2021 - 06.2022
Continuous Improvement Specialist
Westlake Convalescent Hospital
06.2020 - 07.2021
- ASQ-Certified Quality Improvement Associate, 01/01/24
- ISO 14971:2019 Risk Management - Medical Device, 01/01/22
- ISO 13485:2016 Requirements - Medical Device QMS, 01/01/22
- ISO 13485:2016 Internal Auditor - Medical Device QMS, 01/01/22
- FDA 21 CFR 820 cGMP Requirements, 01/01/22
- Failure Mode and Effective Analysis, 01/01/22
- ISO 13485:2016 - Design and Development of Medical Device, 01/01/22
- Medical Device Regulation (MDR), 01/01/22
- Project Management Foundations, 01/01/21
Master of Science - Health Care Administration
California State University, East Bay (CSUEB)
Bachelor of Science - Biomedical Engineering
D. J. Sanghvi College of Engineering
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