Abdelrahman Haifawi
Senior Regulatory Affairs & Quality Manager at Cara Care- Claim this Profile
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German Full professional proficiency
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Arabic Native or bilingual proficiency
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English Native or bilingual proficiency
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Greek Elementary proficiency
Topline Score
Bio
Thiago Barretto
I had the previlege to coach Abdelrahman during his time at Nipro as RAQA Engineer and QMB. Abdel was an outstanding employee, extremelly engaged, dedicated and professional. He didn´t count the working hours needed to accomplish his targets and keep our customers satisfied. He was permanently reading and researching to be able to adapt to the constant new requirements in the Medical Devices industry. Also personally he had excellent relation with supervisors and colleagues, being well accepted by all. I wish Abdel all the best for his future career.
LinkedIn User
I am writing this letter to strongly recommend Mr. Abdel Rahman for your program. I worked with him during the transition from MDD to MDR for the NPW medical devices. He successfully defined the basis of the Technical Documentation for the first device placed on the market of NME manufacturing plants under MDR. He put in extra hours as necessary in order to meet the required deadlines of the project. He demonstrated technical knowledge, excellent communication skills and always positive attitude valued not just by myself, also for the rest of RA/QA NME team. If you need more references, do not hesitate to contact me. Sincerely, Ivan Canal RA/QA Manager NME Plants
Thiago Barretto
I had the previlege to coach Abdelrahman during his time at Nipro as RAQA Engineer and QMB. Abdel was an outstanding employee, extremelly engaged, dedicated and professional. He didn´t count the working hours needed to accomplish his targets and keep our customers satisfied. He was permanently reading and researching to be able to adapt to the constant new requirements in the Medical Devices industry. Also personally he had excellent relation with supervisors and colleagues, being well accepted by all. I wish Abdel all the best for his future career.
LinkedIn User
I am writing this letter to strongly recommend Mr. Abdel Rahman for your program. I worked with him during the transition from MDD to MDR for the NPW medical devices. He successfully defined the basis of the Technical Documentation for the first device placed on the market of NME manufacturing plants under MDR. He put in extra hours as necessary in order to meet the required deadlines of the project. He demonstrated technical knowledge, excellent communication skills and always positive attitude valued not just by myself, also for the rest of RA/QA NME team. If you need more references, do not hesitate to contact me. Sincerely, Ivan Canal RA/QA Manager NME Plants
Thiago Barretto
I had the previlege to coach Abdelrahman during his time at Nipro as RAQA Engineer and QMB. Abdel was an outstanding employee, extremelly engaged, dedicated and professional. He didn´t count the working hours needed to accomplish his targets and keep our customers satisfied. He was permanently reading and researching to be able to adapt to the constant new requirements in the Medical Devices industry. Also personally he had excellent relation with supervisors and colleagues, being well accepted by all. I wish Abdel all the best for his future career.
LinkedIn User
I am writing this letter to strongly recommend Mr. Abdel Rahman for your program. I worked with him during the transition from MDD to MDR for the NPW medical devices. He successfully defined the basis of the Technical Documentation for the first device placed on the market of NME manufacturing plants under MDR. He put in extra hours as necessary in order to meet the required deadlines of the project. He demonstrated technical knowledge, excellent communication skills and always positive attitude valued not just by myself, also for the rest of RA/QA NME team. If you need more references, do not hesitate to contact me. Sincerely, Ivan Canal RA/QA Manager NME Plants
Thiago Barretto
I had the previlege to coach Abdelrahman during his time at Nipro as RAQA Engineer and QMB. Abdel was an outstanding employee, extremelly engaged, dedicated and professional. He didn´t count the working hours needed to accomplish his targets and keep our customers satisfied. He was permanently reading and researching to be able to adapt to the constant new requirements in the Medical Devices industry. Also personally he had excellent relation with supervisors and colleagues, being well accepted by all. I wish Abdel all the best for his future career.
LinkedIn User
I am writing this letter to strongly recommend Mr. Abdel Rahman for your program. I worked with him during the transition from MDD to MDR for the NPW medical devices. He successfully defined the basis of the Technical Documentation for the first device placed on the market of NME manufacturing plants under MDR. He put in extra hours as necessary in order to meet the required deadlines of the project. He demonstrated technical knowledge, excellent communication skills and always positive attitude valued not just by myself, also for the rest of RA/QA NME team. If you need more references, do not hesitate to contact me. Sincerely, Ivan Canal RA/QA Manager NME Plants
Credentials
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Information Security Officer
TÜV Rheinland GroupJan, 2023- Sep, 2024 -
Process Design, Scale-up and Technology Transfer for Medical Devices
Symmetric TrainingOct, 2021- Sep, 2024 -
Specialist for Quality Management in the Medical Device Industry according to ISO 13485:2016 - TÜV
TÜV SÜDJul, 2021- Sep, 2024 -
DNA Sequences: Alignments and Analysis
University System of MarylandAug, 2020- Sep, 2024 -
Mechanical Ventilation for COVID-19
Harvard Medical SchoolJun, 2020- Sep, 2024 -
Statistical Analysis in Bioinformatics
University System of MarylandJun, 2020- Sep, 2024
Experience
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Cara Care
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Netherlands
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Hospitals and Health Care
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1 - 100 Employee
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Senior Regulatory Affairs & Quality Manager
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Jul 2022 - Present
*Head of RAQA Department*In charge of internal and external audits* Responsible for the Risk management system according to ISO 14971* Responsible for the Information Security Management System according to ISO 27001
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QM Representative/PRRC
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Jul 2022 - Present
*Quality Management Representative | ISO 13485*Person Responsible for Regulatory Compliance | EU 2017/745 MDR
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AESKU.GROUP
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Germany
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Biotechnology Research
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1 - 100 Employee
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Regulatory Affairs Manager
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Mar 2022 - Jul 2022
*In charge of risk management system according to ISO 14971*Creation and upkeep of Technical Documentation according to IVDR *In charge of registration of products in international markets *In charge of risk management system according to ISO 14971*Creation and upkeep of Technical Documentation according to IVDR *In charge of registration of products in international markets
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Nipro Pure Water
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Germany
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Management Representative, ISO 13485
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Oct 2021 - Mar 2022
* In charge of the Quality Management System according to ISO 13485* Quality management representative* Promote internal consciousness about quality, the environment and expectations from customers.* Directly lead and manage NPW internal audit , audit process and timetable.
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RA/QA Engineer
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Apr 2021 - Mar 2022
* Implementing and monitoring changes in the Regulatory field affecting the company, its products or environment. Actively monitor EU regulation, MDD and MDR.* Managing all regulatory and quality documentation connected with medical devices; records, document preparation, document approvals and document release.* Managing the Corrective and Preventive Actions system, monitoring non-compliances, customer complaints and satisfaction, leading corrective actions and undertaking follow up.* Responsible for the whole international registration.* Establishing quality agreements with the company's partners
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Teleperformance
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United States
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Outsourcing and Offshoring Consulting
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700 & Above Employee
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Customer Care Supervisor
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Jan 2020 - Apr 2021
Handling various projects for the German and Austrian markets by:*Change management processes implementation*Handling regional escalations*Qualitative and quantitative measures and control*Talent development trainer*Human resources allocation*Managing daily operations
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Customer Care Representative
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Jun 2019 - Dec 2019
Customer care and technical support for the German speaking countries (DACH).
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ALTEN Technology
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Germany
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Aviation and Aerospace Component Manufacturing
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1 - 100 Employee
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Biomedical Engineer
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Jul 2018 - Jan 2019
Project engineer in Ergonomics study for Airbus.The study involved systematically analyzing over 2,000 work packages, where technicians assembled parts of the Aero-structure and the ergonomic impact this has on different parts of their bodies.Process Optimization engineer for Inventory Planning and Tooling Operations for A400M airplanes in Airbus, Bremen, Germany. Project engineer in Ergonomics study for Airbus.The study involved systematically analyzing over 2,000 work packages, where technicians assembled parts of the Aero-structure and the ergonomic impact this has on different parts of their bodies.Process Optimization engineer for Inventory Planning and Tooling Operations for A400M airplanes in Airbus, Bremen, Germany.
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Co-Founder
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May 2015 - Jul 2018
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Dräger
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Germany
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Manufacturing
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700 & Above Employee
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internship and graduation project
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Sep 2016 - Jun 2017
I was fortunate to work in research and development department at Drägerwerk AG & Co. KGaA in Germany, Lübeck. I was the pioneer in creating such a medical tool to read, save and receive medical data from ventilators and anaesthesia devices through physical communication channel. The aim of this program was to suggest new parameters to reach the perfect parameters for the patients to avoid mucus embedding in the patient lung during ventilation or anaesthesia without harming the patients.After 6 months of working on that project, I did my graduation project developing the same program such as (implementing different ventilation modes for different types of Dräger devices, enhancing the graphical user interface to be friendly programmed to all anesthesiologists and therapists with respect to all factors in the operation rooms or in the ICUs and implementing all patient categories such as neonates, infants and adults).
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Education
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2012 - 2018
German Jordanian University
Bachelor's degree, Biomedical/Medical Engineering -
2020 - 2020
University of Maryland
MicroMaster, Bioinformatics -
2016 - 2016
Fachhochschule Lübeck
Bachelor's degree, Biomedical/Medical Engineering
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