نجوى خيري

Quality & Regulatory Lead Auditor
DEKRA Certification BV
📅 2021-Current San Diego CA Remote Home Office
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DEKRA Certification B.V. is a globally recognized Notified Body and certification organization based in the Netherlands, specializing in conformity assessments for medical devices, in vitro diagnostics, and quality management systems under EU MDR, IVDR, ISO 13485, and MDSAP.
Striving to deliver efficient, respectful, and value-added audits that support client growth and compliance. My goal is to ensure each audit is a respectful, insightful, and stress-free process for our clients. Specialized in EU regulatory compliance, including Medical Device Regulation (MDR - EU 2017/745) and In Vitro Diagnostic Regulation (IVDR - EU 2017/746), with hands-on experience in leading audits, conformity assessments, and certification processes.

• Planned and Led audits to EU MDR/IVDR, ISO 13485, ISO 9001 and MDSAP requirements for global clients.
• Assessed quality systems for regulatory and standard compliance, identifying and documenting clear, evidence-based findings.
• Ensured impartiality and compliance with Notified Body and accreditation standards.
• Delivered accurate, high-quality audit reports within strict deadlines.
• Fostered transparent, professional communication throughout the audit lifecycle.
• Stayed current with evolving regulations and contributed to certification decisions as needed

Client Manager
BSI (British Standards Institution)
📅 2019-2021 Remote San Diego CA Remote Home Office

BSI (British Standards Institution) is a leading UK Notified Body, recognized for providing CE certification services under EU MDR and IVDR. Trusted globally for rigorous conformity assessments that ensure product safety, quality, and regulatory compliance.
• Delivered BSI audit services across industries in compliance with ISO 13485, EU MDR/IVDR, and CE Marking requirements.
• Managed a diverse client portfolio, ensuring timely, cost-effective, and high-quality assessments.
• Planned, scheduled, and conducted audits independently, from initial contact to final reporting.
• Assessed Quality Management Systems for regulatory compliance and continuous improvement.
• Maintained accurate client records, audit cycles, and reporting using BSI tools (e.g., PointGlobal).
• Mentored and coached new auditors to ensure consistent delivery and knowledge transfer.
• Promoted BSI services and training solutions to support client growth and compliance goals.
• Contributed to business expansion through exceptional service and client relationship management

LabCorp of America is a leading global life sciences Medical Laboratory providing comprehensive clinical laboratory and diagnostic services to support patient care, drug development, and health insights.
• Directed regional quality operations, Lab Accreditation across multiple laboratories, ensuring full compliance with CLIA, CAP, and state regulations.
• Strengthened audit readiness by leading internal audits and successfully reducing external inspection findings by over 40%.
• Oversaw Proficiency Testing (PT) programs to ensure timely review, investigation of failures, and implementation of effective corrective actions.
• Designed and implemented standardized quality metrics, driving accountability and performance improvement across all regional sites.
• Led resolution of CAP inspection deficiencies, achieving timely closure and sustained compliance through robust CAPA systems.
• Developed and facilitated staff training on quality standards, risk management, and regulatory requirements, improving audit outcomes and staff competency.
• Collaborated with laboratory leadership and technical teams to embed a culture of continuous improvement and regulatory excellence.
• Provided quality oversight during lab expansions, relocations, and system integrations, ensuring seamless transitions and minimal disruption to operations.
• Recognized for elevating regional quality performance and aligning practices with national quality strategy.

Alere specializes in point-of-care and laboratory diagnostics, offering innovative IVD solutions. Now part of Abbott, the company continues to deliver advanced diagnostic tools for faster, more accurate clinical decision-making
• Validated and supported IVD ELISA kits and ISO 13485-compliant lab instruments.
• Delivered on-site customer training, technical support, and instrument software validation.
• Served as regional expert on CLIA, CAP tests requirements for Alere products.

Quest Diagnostics is a leading provider of diagnostic testing, laboratory services, and health information, supporting clinical decisions through high-quality lab results and innovative health solutions.
• Directed quality system implementation across 157+ California sites, ensuring full CLIA, CAP, and state regulatory compliance.
• Conducted internal audits, managed complaints and CAPAs, and streamlined lab-to-patient processes for greater efficiency.
• Developed and launched training programs, SOPs, and competency tools served as the primary lead for licensure and accreditation compliance.

Palo Alto Medical Foundation (PAMF) is a not-for-profit healthcare organization affiliated with Sutter Health, providing comprehensive medical services including primary care, specialty care, and laboratory services throughout Northern California.

• Led setup and validation of new IVD instruments for PAMF’s 301 lab launch.
• Updated SOPs and training manuals; trained and supervised new CLS staff.
• Oversaw quality control, instrument/method comparison programs, and regulatory documentation.
• Performed high-complexity testing across Hematology, Chemistry, Immunology, Blood Bank, and specialized assays.
• Managed CAP surveys and staff competency assessments to ensure ongoing compliance.

• Provided expert technical and QC support for coagulation instruments and assays across the Western region.
• Led validation studies, lot-to-lot QC analysis, and troubleshooting in high-complexity labs.
• Trained and mentored lab managers and supervisors; developed SOPs and adaptation protocols.
• Analyzed instrument performance data in compliance with CLIA and CAP requirements.
• Supported cost-efficiency goals through reagent and consumable QC monitoring.

Stanford Hospital is a world-renowned academic medical center and part of Stanford Health Care. Located in Palo Alto, California, it provides cutting-edge patient care, advanced medical research, and serves as the primary teaching hospital for Stanford University School of Medicine.

• Performed and validated high-complexity testing across departments: Microbiology, Virology, Flow Cytometry, Chemistry, Hematology, Coagulation, and PCR.
• Led QC processes for reagent and kit validations; ensured timely and accurate lab results.
• Trained new CLS staff and managed lab inventory and QC tracking systems.
• Conducted shell vial prep, virus inoculation (e.g., Rhesus), and fluorescent slide staining.
• Ensured regulatory readiness by monitoring QC logs and resolving sample/information discrepancies.

IBT Technical Institute, also known as IBT Tech, was a career-focused vocational school based in Santa Clara (Silicon Valley), California, serving for over 50 years.

• Led and trained a cohort of 37 Medical Assistant, Lab Assistant, Phlebotomy, and EKG students—achieving a 97% national certification pass rate.
• Developed ESL-friendly teaching materials, delivered hands-on hospital-based training.
• Helped place 10+ graduates at Stanford Hospital.

Buyu Quan Medical Laboratory was a privately established diagnostic lab in Africa, founded to address local healthcare needs. It provided essential medical testing services, introduced new diagnostic technologies, and played a key role in public health efforts, most notably in detecting and managing Chloroquine-resistant malaria. The lab also served as a training and employment hub for local healthcare professionals.

• Founded and led a private diagnostic lab, expanding access to medical services in the community. Oversaw all operations from feasibility and staffing to budgeting Sales and market expansion. Launched a distribution arm for diagnostic products and led a major public health initiative targeting Chloroquine-resistant malaria. Directed clinical research from concept to completion, ensuring data integrity and team performance.

Elan Woodruff Health Center is a public health laboratory—and a WHO, NGO, or government-affiliated facility—focused on medical eligibility screening for migrants and immigrants. In practice, it appears to have served similar functions to Khartoum's core public health laboratories.

• Oversaw lab operations and supply chain for medical screenings supporting NGOs and immigration health assessments for U.S. and Canadian entry. Delivered accurate, high-quality diagnostic reports.
• Optimized Lab Performance: Streamlined operational workflows, improving turnaround time by 30% and enhancing testing accuracy through advanced QA/QC systems.
• Regulatory Excellence: Achieved full compliance with and other regulatory standards during audits, with zero major nonconformities.
• Strategic Leadership: Directed multi-site laboratory operations, overseeing staffing, budgeting, equipment validation, and LIS integration across high-complexity labs.
• Team Development: Built and mentored cross-functional teams, increasing staff retention by 40% through training programs and professional development initiatives.
• Innovation & Automation: Led successful implementation of automated platforms and digital tools, reducing manual errors and increasing throughput by 50%.
• Cost Control: Reduced operational costs by 25% through lean process improvements, vendor negotiations, and inventory optimization.
• Crisis Management: Maintained business continuity and diagnostic reliability during public health emergencies lab protocols.
• Collaboration & Growth: Partnered with hospital systems, public health agencies, and research institutions to expand testing capabilities and launch new service lines.