Mahmoud Elbalawy
Brentwood
Summary
Accomplished Quality Assurance leader with over 20 years of progressive experience in the medical device and life sciences industries, specializing in the development and scaling of high-performing, multi-site Quality organizations. Proven track record of advancing regulatory compliance, operational excellence, and key strategic initiatives, with a strong emphasis on fostering a culture of quality. Recognized for effectively managing successful FDA responses and establishing efficient comprehensive QMS processes. Technically sound ASQ Certified Quality Engineer and Lead Auditor, distinguished by exceptional leadership skills and a commitment to cross-functional collaboration.
Overview
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Certification
Work History
Sr. Director, Quality Operations, Americas
Olympus Surgical Technologies of the Americas
San Jose, CA
2023 - 2026
- Achieved high standards in quality operations across 13 manufacturing and repair sites in North and South America. Acted as head of quality and represented management, fostering a culture of excellence.
- Directed remediation and closure of multiple FDA Form 483 observations by implementing effective and sustainable corrective and preventive actions (CAPAs).
- Established a standardized regional quality management system (QMS) that optimized procedures and fostered a high-performing on-site quality organization and technology infrastructure. Transformed operations across sites, resulting in enhanced process consistency and accelerated decision-making and compliance execution.
- Drove significant enhancements in validation processes for test methods in manufacturing laboratory equipment calibration and qualification programs, leading to stronger quality assurance. Elevated validation rigor and documentation practices, which improved reliability, ensured data integrity, and bolstered regulatory compliance throughout the product lifecycle.
- Directed the implementation of high-impact operational excellence initiatives at both regional and site levels. Oversaw the optimization of tooling and fixtures to enhance efficiency and effectiveness. Championed KPI governance and audit readiness programs to elevate compliance standards.
- Achieved successful management of global quality system and site-level quality leadership aligned with a lean operational model. Delivered full regulatory compliance across diverse jurisdictions while maximizing resource utilization and driving operational improvements.
- Enhanced team accountability and performance through strategic people leadership and talent development initiatives. Cultivated a high-performing quality organization characterized by a culture of ownership, continuous improvement, and cross-functional teamwork.
Principal Quality Engineering Manager
Amazon Lab 126
Sunnyvale, CA
2022 - 2025
- Directed quality engineering initiatives for confidential Class II/III medical devices and oncology therapeutics.
- Directed the overhaul of design history files and risk management documentation for a portfolio of legacy medical devices. Led comprehensive gap assessments to elevate technical documentation to meet current standards. Enhanced risk files to bolster regulatory compliance and prepare for audits. Strategically mitigated compliance risks throughout the entire product lifecycle.
- Achieved regulatory compliance by delivering a standalone quality management system (QMS) that meets 21 CFR 820 and ISO 13485 standards for a new business unit. Cultivated core processes, procedures, and documentation for the QMS, enabling smooth regulatory approval and effective launch of business unit operations.
- Achieved significant enhancements in patient safety and regulatory compliance through the establishment of a robust global post-market surveillance program. Implemented systematic processes for complaint handling, trend analysis, vigilance reporting, and proactive risk monitoring to drive continuous product improvements. Leveraged real-world data to inform product enhancements and ensure ongoing safety and compliance.
Sr. Director, Quality Assurance (Consulting)
Predicine Inc.
Hayward, CA
2021 - 2022
- Directed global quality assurance initiatives for precision medicine and companion diagnostics firm.
- Engineered and implemented FDA specific Quality Management System (QMS) alongside a comprehensive Contract Manufacturing Organization (CMO) and supplier quality program.
- Directed quality initiatives to enhance PMA EUA and IRB submission processes for companion diagnostics.
Sr. Director, Quality Assurance
Pfizer (Formerly Lucira Health)
Emeryville, CA
2020 - 2021
- Led strategic initiatives to secure FDA Emergency Use Authorization (EUA) and 510(k) clearance for pioneering at-home PCR COVID-19 test.
- Led cross-functional teams in the successful attainment of ISO 13485 certification for the entire quality management system.
- Designed and launched robust complaint handling and global post-market surveillance initiatives to enhance product safety and compliance.
Director, Quality Operations & Design Assurance
JUUL Labs
San Francisco, CA
2018 - 2020
- Directed quality operations in APAC and coordinated new product introduction efforts across North America and EMEA to ensure compliance and operational excellence.
- Managed quality assurance initiatives throughout the entire operational lifecycle, encompassing supplier development, installation, and ongoing service support.
- Directed quality assurance processes for FDA pre-market application and UK MHRA Class IIA submission.
Supplier Quality Manager
23andme
Mountain View, CA
2018 - 2020
- Developed supplier quality assurance processes to enhance product reliability and compliance.
Sr. Quality Engineer
Johnson & Johnson
San Carlos, CA
2016 - 2018
- Led quality assurance initiatives to enhance product reliability and reduce defects.
Quality Assurance Manager
Benvenue Medical
Santa Clara, UT
2014 - 2016
- Led quality assurance initiatives to enhance product compliance with regulatory standards.
Education
Bachelor of Science - Cell and Molecular Biology, Biochemistry
Winona State University
Winona, MN2005
Dual MBA/MS - Biomedical Engineering
Purdue University
Indianapolis, INSkills
- Collaborative leadership
- Organizational culture change
- Team development
- Regulatory framework design
- Change management expertise
- Quality compliance
- FDA/ISO Quality Systems
- Process development
Certification
- ASQ Certified Quality Engineer (CQE) – License #62898
- ASQ Certified Quality Auditor (CQA) – License #64101
- BSI Certified ISO 13485:2016 Lead Auditor
- Wharton Business School Leadership Certificate
Timeline
Sr. Director, Quality Operations, Americas
Olympus Surgical Technologies of the Americas
2023 - 2026
Principal Quality Engineering Manager
Amazon Lab 126
2022 - 2025
Sr. Director, Quality Assurance (Consulting)
Predicine Inc.
2021 - 2022
Sr. Director, Quality Assurance
Pfizer (Formerly Lucira Health)
2020 - 2021
Director, Quality Operations & Design Assurance
JUUL Labs
2018 - 2020
Supplier Quality Manager
23andme
2018 - 2020
Sr. Quality Engineer
Johnson & Johnson
2016 - 2018
Quality Assurance Manager
Benvenue Medical
2014 - 2016
Bachelor of Science - Cell and Molecular Biology, Biochemistry
Winona State University
Dual MBA/MS - Biomedical Engineering
Purdue University