SUNNY LAST NAME
New York,NY
Summary
Results-driven Product Quality Control Specialist with extensive experience at Varian, adept in CAPA management and root cause analysis. Proven track record in ensuring FDA and ISO compliance, leading audits, and enhancing QMS metrics. Skilled in training teams and fostering continuous improvement initiatives, while maintaining a strong focus on product release readiness. Orderly Quality Control Specialist with keen eye for detail and results-driven approach. Working computer knowledge and proficiency in job-related software. Systematic Quality Control Specialist offers root cause analysis, project coordination, and quality assurance expertise paired with outstanding multitasking and communication abilities. Focused and determined professional with many years of vast experience checking outgoing product quality. Solid grasp of product testing techniques and manufacturing processes.
Overview
2026
2026
years of professional experience
Work History
Product Quality Control Specialist
Varian – A Siemens Healthineers Company
Palo Alto, CA
10.2022 - Current
- Conduct internal audits and review Device History Records (DHRs) to ensure compliance with FDA, ISO 13485, and GMP standards.
- Manage and resolve nonconformances; lead CAPA root cause investigations and implementation.
- Compile and present QMS metrics; contribute to continuous improvement and risk mitigation initiatives.
- Support cross-functional product release readiness and tooling validation efforts.
- Train inspectors and align procedures with evolving quality system requirements.
- Lead process audits and collaborate with engineering on quality-impacting changes.
QA Product Release Associate II
Boston Scientific
San Jose, CA
01.2015 - 01.2022
- Led GMP-compliant batch record reviews and final product release activities for Capital Equipment.
- Executed MES and SAP transactions and maintained documentation per GDP and regulatory requirements.
- Oversaw nonconformance dispositions (RTVs, F2QNs, Scrap) and compiled MRB metrics for management reporting.
- Supported internal and external audits, ensuring full document traceability and inspection readiness.
- Processed OEM inspections and return transactions; tracked production cycle times.
- Trained new QA personnel and contributed to procedure and Work Instruction updates.
QA Product Release Associate
Boston Scientific
San Jose, CA
01.2010 - 01.2015
- Reviewed DHRs and coordinated final product reviews, including label and shipment verifications.
- Released standard work orders to sterilization and distribution partners; created sterile loads in SAP.
- Reviewed sterilization run reports and submitted PSRR forms in accordance with regulatory expectations.
- Coordinated LAL testing with third-party labs and reviewed compliance results.
- Maintained DHR master database and provided audit support.
- Initiated NCMRs and supported CAPA investigations.
- Participated in new product launches, identifying potential quality risks prior to release.
QA Associate Lead
GDM Electronic & Medical
Milpitas, CA
- Supervised QA procedures and documentation reviews to ensure ISO and GMP compliance.
- Led inspection workflows and supported process improvement initiatives across production.
Education
Bachelor’s Degree - Business Administration
Universidad del Valle de México
Skills
- CAPA Management & Root Cause Analysis
- Internal & External Audit Support
- FDA, ISO 13485, MDR, GMP Compliance
- Quality System Documentation & Control
- QMS Metrics & KPI Reporting
- Product Release & DHR Audits
- MES, SAP, Windchill, ETQ, FileMaker Pro
- Standards & Regulatory Tracking
- Team Mentorship & Training
- Fluent in English and Spanish
- QMS Systems: MES, SAP, ETQ, Windchill, FileMaker Pro, DocuSign
- Office Tools: Microsoft Word, Excel, PowerPoint, Power BI, Teams, Workday
- Equipment Knowledge: Inspection tools, metric scales, assembly tools
- Regulatory Familiarity: FDA, ISO 13485, ISO 14001, MDD/MDR
Languages
Bilingual: English & Spanish
Timeline
Product Quality Control Specialist
Varian – A Siemens Healthineers Company
10.2022 - Current
QA Product Release Associate II
Boston Scientific
01.2015 - 01.2022
QA Product Release Associate
Boston Scientific
01.2010 - 01.2015
QA Associate Lead
GDM Electronic & Medical
Bachelor’s Degree - Business Administration
Universidad del Valle de México
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