Heba Nagy

Quality-driven and technically accomplished Laboratory Professional with over 15 years of robust experience spanning microbiology diagnostics, laboratory quality management, and automated systems within CAP-accredited environments. Offers a powerful blend of hands-on technical expertise and growing specialized knowledge in medical device regulations, including ISO 13485, IVDR (EU 2017/746), and CE Marking. Currently pursuing a Master's Degree in Healthcare Quality to further bridge the gap between clinical excellence and regulatory compliance.

Seeking to leverage deep clinical diagnostic experience and quality systems expertise to transition into impactful roles within the IVD and healthcare industries, such as Regulatory Affairs Specialist, Technical Support Specialist, Application Specialist, or Quality Assurance Specialist.

CAP Quality Officer (Microbiology Unit) at Alfa Laboratories (2025-01 – Present)

• Driving readiness and compliance activities for prestigious accreditations including CAP, ISO 15189, and ISO 17025.
• Managing end-to-end CAPA processes and non-conformity investigations utilizing structured root cause analysis (RCA) methodologies.
• Leading method verification and validation studies in alignment with CLSI guidelines, utilizing EP Evaluator to ensure technical compliance.
• Overseeing quality documentation, SOP drafting, and rigorous document control systems.
• Facilitating internal and external audit preparation, execution, and comprehensive follow-up reporting.
• Monitoring key quality indicators and collaborating with cross-functional teams to optimize laboratory workflows, operational efficiency, and biosafety programs.

Senior Microbiologist at Alfa Laboratories (2016-01 – 2025-01)

• Provided crucial first-line technical and application support for laboratory users, staff, and clinicians regarding diagnostic outcomes.
• Operated, maintained, and masterfully troubleshot complex automated diagnostic platforms (VITEK 2, Bio Fire Film Array, Sysmex, ELISA platforms).
• Executed complex method verification/validation studies encompassing accuracy, precision, reproducibility, and rigorous QC assessments.
• Implemented comprehensive quality control programs and actively drove External Quality Assessment (EQA/PT) activities.
• Contributed to workflow optimization projects that significantly elevated laboratory throughput and efficiency.

Microbiologist at Alfa Laboratories (2009-01 – 2016-01)

• Performed high-complexity microbiological testing including clinical culture, bacterial identification, and antimicrobial susceptibility testing (AST).
• Assisted in initial ISO 15189 compliance setups and routine quality control monitoring.

Master's Degree in Healthcare Quality – Arab Academy for Science, Technology and Maritime Transport (2024-01 – 2026-09)

Diploma in Applied Microbiology – Cairo University (2014-01 – 2015-01)

Bachelor's Degree in Chemistry and Biology – Cairo University