Rania Gerges

QMS & Statistics Expert

Rania Gerges
Quality Assurance Consultant 

Rania brings to Qserve more than 12 years of experience in product development, quality engineering, and quality management system development. Rania has held various positions in small and large medical device companies, developing a diverse range of devices; including neuro-regenerative and interventional devices, dental restorative devices, and video integration capital systems.   

At the beginning of Rania’s career, she worked at DEKRA Notified Body (formerly KEMA) where she gained strong foundations in EU regulations, CE technical file assessments and auditing to ISO 13485 and the EU-MDD. This experience has significantly shaped Rania’s career as later she held Quality Engineer positions, in which she developed a passion for quality while always integrating the underlying regulations for the everyday tasks of what she accomplished. Rania did not separate the field of quality from regulatory, and that made her an exceptional and a go-to engineer in both Integra Lifesciences and Zimmer Biomet for product development, quality engineering, and regulatory guidance.   

Rania has an extensive hands-on experience in successful delivery of quality engineering results. She has been leading activities such as design control cycle, risk management, sterilization, biocompatibility and shelf life studies, design verifications, process validations, test method validations, sampling plans, CAPAs, NCs, post-market surveillance, internal and supplier audits. Prior to Zimmer Biomet, Rania constructed and implemented a quality management system in a startup company to resolve FDA 483s and a US FDA warning letter, and 6 months later, she passed an FDA inspection conducted by one of the toughest inspectors in the US.   

Rania has a bachelor’s degree in Biomedical Engineering from Drexel University and a master’s degree in Applied Statistics from Rochester Institute of Technology. Rania is a Certified Quality Engineer by the American Society of Quality and she is a Certified ISO 13485:2016 Lead Auditor.    

About working at Qserve:
“I am honored to be part of a global medical device consultancy team highly skilled in the field of regulatory affairs and compliance, quality management system, auditing, clinical affairs and training. I am excited about this rewarding career journey, in which I contribute to Qserve’s mission to help improve patient safety and health through supporting the advancement of medical devices companies. This move will not only sharpen my current skills, but it gives me an opportunity to develop new ones in the innovative field of medical devices.”     

Are you a startup company and need to establish and implement a sustainable and efficient quality management system? Need to conduct a thorough internal audit of your quality management system, or for your suppliers? Or seek help from streamlining and closing your CAPA backlog? Get in touch with us.  

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