Quality Assurance Senior Manager
Resume:
ORANGE, US, ***** • *************@*****.*** • 951-***-****
WWW.LINKEDIN.COM/IN/TRISHAFUENTEZ
TRISHA FUENTEZ
Senior Manager Quality Assurance
PROFESSIONAL SUMMARY
Senior Manager Quality Assurance with extensive experience in the life science and medical device sectors, leveraging over 20 years of expertise in quality assurance, change management, and training. Demonstrates visionary leadership in eQMS implementation and process improvement, achieving significant cost savings and operational enhancements. Committed to fostering a culture of continuous excellence and innovation, adhering to FDA compliance standards and driving cross-functional collaboration. SKILLS & EXPERTISE
Quality Systems Software Validation Software Validation Audits Data Migration eQMS Configuration/ Implementation Change Management Training Quality Metrics
Process Improvement Gap Analysis CAPA/Non-Conformance EMPLOYMENT HISTORY
NATERA, INC. – SAN CARLOS, CA SEP 2023-PRESENT
Quality Assurance Manager
Lead QA team, ensuring compliance with US and International Standards, optimizing product quality. Mentor QA staff, fostering development and succession planning, enhancing team capabilities.
Collaborate cross-functionally to resolve critical issues, ensuring timely, high-quality product releases. Drive continuous improvement in QA practices, maintaining rigorous standards for medical devices. Spearhead initiatives to align with CAP/CLIA and ISO 13485.
Streamline QA processes, significantly reducing defects and enhancing product reliability. Implement strategic improvements for measurable quality gains.
Partner cross-functionally to resolve critical issues, ensuring timely product releases. Spearhead initiatives aligning with CAP/CLIA and ISO 13485 requirements.
Implement strategic QA process improvements, significantly reducing defects and enhancing product reliability. Drive measurable quality gains through innovative approaches.
Optimize product quality through data-driven strategies. Streamline QA processes, delivering tangible improvements in product performance and customer satisfaction.
Develop forward-thinking QA strategies, anticipating industry trends. Foster a culture of excellence, positioning the team as quality leaders in medical device manufacturing.
REJUVENATE BIO – SAN DIEGO, CA OCT 2021 –
Senior Manager, Quality Assurance
Lead QA team to ensure compliance with global standards, optimizing product quality. Mentor staff, fostering development and enhancing team capabilities.
Monitor lab personnel training compliance. Track training adherence data and report monthly QI metrics, driving continuous improvement in QA practices.
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Implemented eQMS software early, increasing productivity. Facilitated cross-department collaboration for document approvals. Optimized audit processes, ensuring consistent product excellence.
Orchestrated cross-functional reviews, fostering effective interdepartmental communication. Facilitated seamless document approvals, improving organizational efficiency.
Pioneered forward-thinking quality assurance strategies, positioning the organization for future regulatory demands. Led initiatives to cultivate a culture of continuous improvement. SONENDO INC. – LAGUNA HILLS, CA MAR 2017 – SEP 2021 Supervisor, Document Control & Training
Led eQMS implementation, boosting efficiency and compliance; reduced CAPA closure time by 80%.
Managed employee training, achieving 96% compliance over 3 years; enhanced eQMS user proficiency.
Conducted internal audits, ensuring zero findings in MDSAP audits: improved change order approvals. Selected cost-effective e-signature software, saving 60% on budget, validated software internally.
Facilitated root cause analysis for CAPAs, significantly improving first-pass yield for change orders.
Revolutionized employee training approach, achieving 96% compliance over 3 years. Significantly improved eQMS user proficiency, fostering a culture of continuous learning.
Conducted meticulous internal audits, resulting in zero findings during MDSAP audits. Streamlined change order approval process, enhancing operational efficiency.
Conducted thorough root cause analyses for non-conformances, enhancing product quality and reliability GLIDEWELL DENTAL– IRVINE, CA – JUN 2016 – FEB 2017 Senior Specialist, Document Control
HBT Labs, Inc – BREA, CA SEP 2014 – JUN 2016
Quality Assurance Specialist
B. Braun Medical Inc. – IRVINE, CA NOV. 2010 – AUG 2011 Technical Writer-Contract
Watson Pharmaceuticals– CORONA, CA JAN 2002 – AUG 2008 Training Coordinator
CERTIFICATIONS
ISO 13485 LEAD AUDITOR CERTIFICATION – BSI
SOFTWARE EXPERIENCE
QAD, QCBD, JIRA, DOC COMPLIANCE, SharePoint, Salesforce, SolidWorks, BDocs, Documentum EDUCATION
Riverside Community College – General Studies
Golden West Community College – General Studies
Redlands Senior High – Diploma
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