Head of Medical Devices at TUV NORD Egypt with end-to-end accountability across marketing, sales, and technical delivery. Lead the full certification lifecycle: manufacturer acquisition (marketing/sales) through to conformity assessment and certificate issuance (technical). Built the division's integrated commercial-technical model from scratch. Fluent in MDR 2017/745, ISO 13485, and Notified Body obligations
Hi, I’m
Omar Hussain
Cairo
Summary
Overview
23
years of professional experience
Work History
TÜV NORD Egypt
Head of Medical Devices / Se Lead Auditor
01.2025 - Current
Job overview
- Senior LA for MDR, ISO 13485, ISO 22000, FSSC 22000, ISO 9001, ISO 45001 and ISO 14001
- IRCA Approved Lead Tutor for ISO 13485, ISO 9001, ISO 45001 and ISO 14001.
- Accountable for the division's end-to-end operations: marketing to attract manufacturers seeking CE marking, sales to close certification contracts, and technical oversight of documentation review, expert assignment, and non-conformity resolution until full certification is achieved.
- Led comprehensive audits to ensure compliance with international standards and regulatory requirements.
- Developed and implemented audit plans, enhancing efficiency and effectiveness of auditing processes.
- Trained and mentored junior auditors, fostering skill development and knowledge transfer within the team.
TÜV NORD EGYPT
Lead Auditor and Tutor
08.2018 - 12.2024
Job overview
- Conduct the Audits as lead auditor for ISO 9001, ISO 14001, ISO 45001, ISO 22000 & FSSC 22000
- Preparing Report packages related to each standard Comply with all Procedures and Policies of the Organization according to ISO 17021
- Lead Tutor for IRCA Lead Auditor Training Courses
TUV Rheinland
Lead Auditor / Trainer
08.2014 - 05.2018
Job overview
- Responsible for the success of the business field, including market analysis, service development, finance, personnel, objectives and measures.
- Define business activities, services to offer and accreditations to obtain (Audit program management in the sense of ISO 17021:2015 AND ISO 19011 GUIDANCE section 5&6).
- Set up an organization structure for service delivery in compliance with accreditation requirements, applicable regulations and the management policy.
- Ensure sufficient resources in coordination with managing director / regional directors. Arrange / participate in the management reviews.
- Arrange for contracting, training and qualification of auditors and technical experts as well as other personnel and coordinating experience exchange.
- Monitor service delivery process including timely surveillance audits.
- Set performance targets (bench marks) and review the realization of the same.
- Ensure that activities (also of related bodies) do not affect the confidentiality, objectivity, or impartiality of the certification process.
- Ensure compliance to the process of the handling customer complaints which includes receipt, record, investigate and resolution of the complaints.
- Ensure compliance to the process of handling appeals, which includes receipt, record, and arrange for the resolution of the appeals.
- As head of certification body (national), ensure that the certification process is performed in accordance with accreditation requirements.
- Appoint auditors and technical experts (if especially authorized for this by the head of the central accredited body).
- Has the final authority regarding all certification decisions and sign the certificates.
- Arrange information flow and auditor experience exchange.
- Ensure effective between communication with management and auditors.
- Ensure conduct of the internal audits and arrange for the review of the results.
- Evaluate auditor performance based on the results of the audit documentation review and arrange for training where required.
AMY International – QS
Management System Lead auditor and Trainer
05.2012 - 06.2014
Job overview
- Establishing initial contact with the audited organization
- Determining the feasibility of the audit
- Performing document review in preparation for the audit
- Preparing the audit plan.
- Assigning work to the audit team.
- Preparing work documents in coordination with back office.
- Conducting audit opening meeting.
- Performing document review while conducting the audit.
- Communicating during the audit.
- Assigning roles and responsibilities of guides and observers during the audit.
- Collecting and verifying information during the audit.
- Generating audit findings.
- Preparing audit conclusions.
- Conducting audit closing meeting.
Future Development institution
Management Systems’ Consultant
05.2010 - 06.2014
Job overview
- Attending meetings with clients and identifying their requirements.
- Preparing site progress reports.
- Approving plans and specification for projects.
- Leading the team during client's project.
- Idea generation and strategy development through to detailed implementation.
- Conduct internal audit and management review meeting before third party audits.
Tag El-Melouk Food Industries Co.
Quality Control Manager
03.2009 - 03.2012
Job overview
- Supervision of quality control team in the 1st shift.
- Responsible for all quality control activities on the production lines in the whole plant.
- Verification of implementation of all production and quality procedures, work instructions on the production lines.
- Assure releasing of high quality products which comply with all finished product specifications' requirements and standards.
- Verification of all raw and packaging materials which found on the production line and review its shelf life and its internal batch number.
- Implementation of the product specification on the production lines (weight, thickness, length, color, odor and its final sealing to assure producing of high quality and safe product).
- Verification of the implementation of cleaning and sanitation programs on the production lines during the line running as well as shut down.
- Implementation of GMP and other prerequisite programs like pest control, traceability, cleaning & sanitation, zoning and hold& release on the production lines.
- Making sure of QC team is obligated with OH&S work instructions.
- Check the PPEs for all QC staff during the working.
- Follow up the environmental measurements after coordinating with QA team (environmental measurements include measuring noise level, gas emission & suspended dust in the work place to take suitable corrective action if exceed the normal level, also the level of contamination in waste water after production to set suitable treatment plan.
Nasser Institute for Research and Development Hospital
Clinical Pharmacist and Lab Supervisor
01.2005 - 02.2009
Job overview
- Medical classes include different classes as mentioned below such as: classes clinical chemistry category, microbiology devices, physical medicine, etc.)
- Main roles related to Medical Devices within the hospital: Provide advice to the staff on all aspects of utilisation relating to the preservation, handing, disposal and all other sterilization requirements for the medical device (such as surgical dressings, wound product, syringes, needles, surgical suture thread, infusion set, etc.) according to the applicable regulations.
- Advise the trust on all matters relating to the use of medical and surgical disposable products and contribute as required to the overall trust strategy and operational requirements for medical devices.
- Review, issuance and updates of all infection control, environmental hygiene and decontamination procedures to the different groups of medical devices according to the applicable regulations.
- Training and awareness to the new staff for the procedures, and the periodic training to other staff according to the training needs and plans.
- Contribute as part of the technical committee in the purchasing process of medical and surgical disposable products to ensure the technical information are communicated to the suppliers in the contracting phase, and that supplier selection, evaluation and re-evaluation are done according to the established criteria.
EIPICO - Egyptian International Company for Pharmaceutical Industries
Quality Control specialist
12.2002 - 12.2004
Job overview
- The scope of EIPICO for medical devices include design, development and production e.g tears eye drops and eye solutions, etc.
- Monitor the production line.
- Inspect Production Lines/areas for GMP compliance, and ensure other medical devices QMS requirements are applied for the EU directive e.g. the sterilization SOPs are communicated, implemented.
- Ensure that samples for microbiological analysis of incoming materials taken in sterile screw capped bottles or disposable sterile containers, for solid or liquid materials under laminar air flow.
- Ensure that samples for chemical analysis of starting materials are being sampled in clean & dry screw capped bottles (disposable sample containers can be used).
- Using suitable Sampling tools e.g. sampling Scoops: (tool is made of stainless steel and is used for sampling solid and semi-solid substances), or spoon (tool is made of stainless steel that serves to take samples from small individual containers).
- Sterile materials, to be tested for sterility should be sampled into sterile screw capped under a laminar flow unit, using sterilized sampling tools in sterility room.
- Compile the technical documentation including: - Technical description, Drawings, circuit diagrams and photos, Specification and Declarations of Conformity for the critical components and materials used, Details of any design calculations, Test reports and/or assessments, Instructions, EC Declaration of Conformity, Analysis of data (Statistical Techniques).
- Sampling and testing of product during manufacturing, filling or packaging according to approved sample plans.
- Assure, implement all the company’s QMS requirements to be compliant with current FDA, ISO 13485, MDD and other standards as applicable.
- Apply all EU directive relevant to the product classification within the management system.
- Implement all requirements of other standards either national; voluntary standards, related to the medical devices within the company.
- Implement any route to conformity of the medical directive at all stages of the product within the production stages, from raw material verification activities as per the directive requirements, to the in-process validation of instruments, work environment, sterilization requirements, to the final release according to the applicable requirements of the Directive(s).
- Ensure all CE requirements and technical file are prepared and updated.
- Take the suitable corrective action required by the company to comply with the directive after each internal or external audits.
- Design and construct technical documentations as detailed in deliverable section where updates is applicable.
- Sampling of blend and/or finished goods for QC release testing according to approved SOPs.
- Complete and maintain quality and production records according to GMP.
- Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
- Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments to production supervisor.
- Approves finished products by confirming specifications; conducting visual and measurement tests; returning products for re-work; confirming re-work.
- Documents inspection results by completing reports and logs; summarizing re-work and waste; inputting data into quality database.
- Keeps measurement equipment operating by following operating instructions; calling for repairs.
- Maintains safe and healthy work environment by following standards and procedures.
- Checking manufactured parts against the specifications and tolerances on the production drawing in order to ensure they meet designated specifications.
- Assisting in checking purchased components for quality before being placed into inventory for use.
- Documenting any and all problems/errors found. and reporting these to the appropriate department for correction.
- Maintaining this documented list and following up on open items until they are fixed and can be closed.
- Documenting process timings for production processes to help ensure the accuracy of information in the company routings.
- Participate in the calibration and qualification activates.
- Participate in trending and periodic reviews.
- In-depth knowledge of GMP, GDP, and pharmaceutical regulatory requirements for storage, handling, and distribution of pharmaceutical products, ensuring compliance with national and international guidelines.
- Proficiency in sampling, testing, and analysing pharmaceutical products to ensure they meet established specifications and quality standards before distribution.
- Ensuring product stability and integrity during storage and distribution by monitoring environmental conditions (e.g., temperature, humidity) and implementing corrective actions when deviations occur.
- Identifying and mitigating risks in storage, handling, and distribution processes to prevent contamination, degradation, or product damage.
- Support in Conducting quality audits of third-party distributors to assess compliance with regulatory and quality requirements.
Education
Faculty of pharmaceutical Science - Tanta UniversityTanta, Egypt
B.Sc. Degree from Pharmaceutical Science
05-2002
University Overview
Attached No.1
Skills
- Microsoft Office
- Internet packages
Timeline
Head of Medical Devices / Se Lead Auditor
TÜV NORD Egypt
01.2025 - Current
Lead Auditor and Tutor
TÜV NORD EGYPT
08.2018 - 12.2024
Lead Auditor / Trainer
TUV Rheinland
08.2014 - 05.2018
Management System Lead auditor and Trainer
AMY International – QS
05.2012 - 06.2014
Management Systems’ Consultant
Future Development institution
05.2010 - 06.2014
Quality Control Manager
Tag El-Melouk Food Industries Co.
03.2009 - 03.2012
Clinical Pharmacist and Lab Supervisor
Nasser Institute for Research and Development Hospital
01.2005 - 02.2009
Quality Control specialist
EIPICO - Egyptian International Company for Pharmaceutical Industries
12.2002 - 12.2004
Faculty of pharmaceutical Science - Tanta University
B.Sc. Degree from Pharmaceutical Science
Present Position
Present Position
- Lead Auditor and Tutor, T
- V NORD EGYPT, Since 08/01/18
Confirmation
Confirmation
04/02/25, Cairo, _____________________Personal Information
Personal Information
- Date of Birth: 01/03/80
- Nationality: Egyptian
Key Qualifications
Key Qualifications
- 02/01/23, PECB Certified ISO 13485 Lead Auditor
- 01/01/23, New Regulation for Medical Devices (EU)2017/745 MDR – General Introduction and Principles – TUV Hellas
- 12/01/22, ISO 13485:2016 quality management system internal auditor – EXAM – TUV Nord
- 12/01/22, Risk analysis and risk management - medical devices based on EN ISO 14971:2020 – exam – TUV Nord
- 01/01/16, Awareness workshop on Notified bodies principles & benefits (The Egyptian Accreditation Council – EGAC)
- 08/01/04, Clinical Practice for Pharmacists (Ministry Of Health and Population)
- 02/01/06, Drugstore Management System (Ministry Of Health and Population)
- 05/01/19, ISO 17021-10 workshop
- 03/01/05, Medical Lab Technologist Diploma from SIRA Academy