Mohd Fuad

Mohd Fuad has 31 years of extensive knowledge and experience in medical devices manufacturing, quality management system, design control, risk management and quality audit (third party, internal and supplier quality audit) in accordance to ISO13485:2016, USFDA 21 CFR Part 820, EU regulation (93/42/EEC and MDR 2017/745) and Malaysia Medical Device Act 2012 (Act 737).

Mohd Fuad has high competency and experiences in the area;

• Quality Management System: 15 years extensive experience and deep knowledge in quality system establishment and maintenance in accordance to the current regulatory and standard requirement; - ISO13485:2016, - MDR 2017/745 and 93/42/EEC, - USFDA 21 CFR part 820 - MDA Act 2012 (Act 737)
• Long and extensive experience in medical devices manufacturing - 15 years’ experience in plastic injection moulding of medical devices, - 15 years’ experience in medical devices assembly i.e. anaesthesia and urology products manufacturing. - 15 years’ experience in medical PVC tube extrusion - 10 years’ experience in procedure pack manufacturing - 6 years’ experience in hypodermic needle and infusion needle manufacturing - 6 years’ experience in medical PVC Intermittence catheters and Heat Moisture Exchange (HME) manufacturing
• Medical Devices Design and Development control; - 15 years extensive experience in establishment of Design and Development control procedure and Design History File maintenance for Class I, II and III except for active implantable medical devices. - Well trained in establish and maintenance Design Dossier and Technical Files of medical devices. Beside that he also actively conducting Design and Development training for local medical devices manufacturers in Malaysia. - Well trained and experience in managing new product development and transfer in accordance to product requirement, user requirement and regulatory requirement based on Concurrent Engineering approach and Industrial Best Practise. - Well experience in compiling Essential Principal of Safety and Performance of medical Devices and managing robust Design Development and Design Verification-Validation activities.
• Medical Devices Product Life-Cycle Management; - Extensive experience in product lifecycle management from material qualification, supplier qualification, supplier assessment and monitoring, product performance qualification and validation, establishment of material and product specification, establishment of testing procedure and test method validation, product and process development, process and manufacturing control, process validation, product shelf-life study, storage and transportation validation, post market surveillance, customer complaint and product performance compilation. - Well trained in managing customer complaint and Field Corrective Action (FCA) including root cause investigation and remediation action
• Manufacturing process control - Six Sigma Certified Engineer by Baxter Quality Institute in product development and manufacturing process. - Well train in SPC – Statistical Process Control implementation. - Well experience in Cp and Cpk process capability monitoring and analysis - Well experience in establishment Critical To Quality (CTQ) and Critical Control Point (CCP) - Extensive experience in implementation and management of Non-Conformance (NC) and (CAPA) Corrective Action and Preventive Action including Problem Solving Technique. - Well experience in managing measurement system/equipment calibration in accordance to local and international standard
• Risk Management of Medical Devices; - Extensive experiences in managing Medical Devices Risk Management requirement and maintaining the risk management file. - Extensive experiences in medical devices risk identification, risk analysis, risk control and residue risk evaluation (risk benefit-ratio) process require by ISO14971. - Well trained in establishment of risk / hazard matrix at life cycle of medical devices as per ISO11971. - Well trained in maintaining the Essential Principles of Safety and Performance (EPSP) of medical devices documentation. - Well trained in establishment and implementation PFMEA and Analysis of Hazard for medical devices at various stages.
• Medical Devices Process Validation; - 15 years extensive experience in managing, plan and executing process validation, automated process validation and Validation Master Plan in accordance to standard and regulatory requirement. - Well trained in conduction test method validated include MSA analysis. - Well trained and highly experience in root caused investigation and remediation in any identified process validation gap.
• EtO Sterilization control and Process Validation - Well trained and extensive experience in managing and execution of EtO Sterilization Process Validation in accordance to ISO1135. - Well trained and extensive experience in reviewing and releasing EO sterilization cycle and re-validation requirement. - Well experience in root cause investigation and improvement process related to EO sterilization.
• Packaging and Sterile Barrier System qualification and Validation - Well trained and extensive experience in design, managing, plan and executing Sterile Barrier/Packaging validation of medical devices in accordance with ISO11607 and regulatory requirement. - Well trained and extensive experience in establish and validating sterile barrier and packaging test methodology in accordance to ISO11607.
• Product Stability and Shelf-life Qualification; - Well trained and extensive experience in conducting stability testing and shelf-life qualification of medical devices as per standard and regulatory requirement. - Deep knowledge in ASTM F1980-21 Accelerated Ageing of Sterile Barrier System and Medical Devices. - Deep knowledge in ASTM D4169 – 22 Standard Practice for Performance Testing of Shipping Containers and Systems in relation to product shelf-life qualification.
• Quality Audit – Third Party, Internal and Supplier Audit - Well trained and extensive experience in managing and conducting internal audit, auditor qualification and provide training in accordance with ISO13485 and regulatory requirement. - Well trained and extensive experience in managing and conducting supplier audit, supplier evaluation/qualification, monitoring and remediation in accordance with ISO 13485 and regulatory requirement. - Extensive experience in hosting and managing planned and unplanned third party audit and regulatory inspection.
• Biocompatibility and Chemical Compatibility as per ISO10993-1 - Extensive knowledge and experience in establishment product biological and chemical safety requirement in accordance with ISO10993-1requirement. - Broad knowledge in performing Biological Evaluation within a risk management process for a medical devices
• Quality Inspection – Incoming, In-process and Outgoing; - Well trained in establishment of product performance testing methodology based on the product requirement profile, established risk control measure and product design requirement. - Well trained in establishment and maintaining the Product Inspection/Testing and Verification Matrix at life cycle of medical devices. - Extensive knowledge in establishment of material testing methodologies such as Tensile Testing, contactless dimensional measurement methodology, visual inspect qualification, chemical inspection methodologies. - Well known in microbiology testing methodologies. - Extensive experience in conducting and managing the incoming, in-process and outgoing quality inspection of medical devices. Well verse in quality inspection sampling plan as per ANSI Z1.4 (for attribute data, i.e., defect counting) and ISO 2859 (the international standard for sampling procedures by attributes)

Working experiences

• 6 years with Teleflex Medical Sdn. Bhd (Taiping, Perak) – From July 2019 to July 2025 Position: Senior Manager, Quality Engineering
• 5 years with B. Braun Medical Sdn. Bhd (Bayan Lepas, Penang) – From Jan 2015 to June 2019 Position: Senior Manager, Quality Management
• 2 years with Johnson & Johnson Medical/ DePuy-Synthes - From September 2012 to December 2014 Position: Senior Quality Manager, Supplier Compliant
• 9 years with ITL Asia Pacific (Ipoh, Perak) – From May 2002 to August 2012 Position: Senior Manager, QARA (4 years) Position: Manager, Research and Development (4 years) Position: Assistant Manager, Research and Development (1 year)
• 9 years with Uno-Medical and Baxter Healthcare (Sg. Petani, Kedah) From May 1993 to April 2002 Position: Engineer, Research and Development / Product Development

Period of Employment: July 2019 – July 2025 (6 years)

Name of Employer: Teleflex Medical Sdn. Bhd. Business Address: Lot No. PT2577, Jalan Perusahaan 4, Kamunting Industrial Estate, 34600 Kamunting, Perak MALAYSIA

Position Held: Senior Manager – Quality Engineering

Summary of responsibilities

• Ensuring that processes needed for the Quality Management System (QMS) are established, implemented and maintained.
• Reporting to Quality Assurance Director on performance of Quality Engineering performance and continuous improvement in Teleflex Kamunting, Perak.
• Ensure the effective implementation and maintenance of Quality Management System to meet ISO, EU/US/JP GMP including FDA / EC and other related regulatory requirements as well as to seek continuous improvement of the Quality Management System with the aim towards Total Quality Management.
• Ensure promotion of quality awareness of regulatory and customer requirements throughout the organization and up to suppliers level.
• Ensuring that change control is implemented in accordance to the standard (ISO 13485) and regulatory requirement USFDA 21 CFR Part 820 and CE Mark.
• Ensuring that the process validation, software validation and test method validation are implemented and in compliance to the regulatory, standard and Teleflex requirement.
• Conduct Gap analysis periodically to ensure that all the validated process status are maintained and implemented.
• Ensuring that CAPA has been effectively implemented as per the standard and regulatory requirement.
• Key person for Risk Management throughout Teleflex Medical Sdn. Bhd. and risk mitigation is appropriately addressed to the acceptable level. To ensure that the residue risk is appropriate addressed and mitigated to ensure the product and patient safety.
• Responsible for incoming raw material inspection and ensure that the raw material specification is up to date and align with the customer and regulatory requirement.
• Ensure that the supplier quality issues are communicated or escalated when necessary and mitigation action are appropriate to ensure that supplier quality are maintained.
• Conduct QMS (ISO 13485:2016) and QSR (21CFR Part 820) training as per schedule established.
• To ensure that the Quality Engineering department operation is within the budget allocation.
• Responsible for process and quality improvement for Teleflex Medical Sdn. Bhd., Kamunting

Period of Employment: Jan 2015 – June 2019 (4 years and 6 months)

Name of Employer: BBraun Medical Industries Sdn. Bhd. Business Address: Bayan Lepas Free Trade Zone, P.O Box 880, 10810 Penang, MALAYSIA

Position Held: Senior Manager – Quality Management

Summary of responsibilities

• Ensuring that processes needed for the Quality Management System (QMS) are established, implemented and maintained
• Reporting to Head of Quality Management on performance of QMS and needs for improvement in BBraun Medical Industries (BMI), Penang.
• Ensure the effective implementation and maintenance of Quality Management System to meet ISO, EU/US/JP GMP including FDA / EC and other related regulatory requirements as well as to seek continuous improvement of the Quality Management System with the aim towards Total Quality Management.
• Ensure promotion of quality awareness of regulatory and customer requirements throughout the organization and up to suppliers level.
• Ensuring that change control is implemented in accordance to the standard (ISO 13485) and regulatory requirement USFDA 21 CFR Part 820 and CE Mark.
• Ensuring that the customer complaint – the complaint file is maintained, investigation is appropriately conducted, Corrective Action and Preventive Action is implemented and MDR is managed as per regulatory requirement
• Ensuring that CAPA has been effectively implemented as per the standard and regulatory requirement.
• Key person for Risk Management throughout the BBraun Medical Industries (BMI) and risk mitigation is appropriately addressed to the acceptable level. To ensure that the residue risk is appropriate addressed and mitigated to ensure the product and patient safety.
• Conduct QMS (ISO 13485:2016) and QSR (21CFR Part 820) training as per schedule established.
• To ensure that the critical processes are validated and revalidated timely manner.
• To ensure that the QM department operation is within the budget allocation.
• Responsible for process and quality improvement for BBraun Medical Industries (BMI) Penang.

Period of Employment: Sep 2012 – Dec 2014

Name of Employer: Johnson & Johnson Medical Sdn. Bhd. Business Address: Unit 11.01, Level 11, Uptown 2, 2 Jalan SS21/37, Damansara Uptown, 47400 Petaling Jaya, Selangor, MALAYSIA

Position Held: Senior Manager – Supplier Quality Compliance (SQC)

Summary of responsibilities

• The Supplier Quality Senior Manager reports directly to the Director, MD&D Supplier Quality and Compliance.
• The Supplier Quality Senior Manager provides leadership in the execution of planned and unplanned supplier quality audits for multiple MD&D operating of Johnson & Johnson companies worldwide to verify compliance to applicable government regulations, industry standards, and to company policies and procedures.
• The Supplier Quality Senior Manager provides supplier compliance expertise to the organization as required.
• The Supplier Quality Senior Manager is responsible for conducting audits and leading a team in the planning and execution of the supplier quality management system.
• This position ensures the implementation of effective global supplier quality systems policies and strategies that align with the MD&D supply chain quality and compliance strategies and global regulatory requirements.
• The Supplier Quality Senior Manager will utilize knowledge of current and emerging regulations and their impact to manage the supplier quality management system.
• Leads the supplier quality management review process and CAPA process related to supplier/EM audits and externally manufactured products.
• Plans the quality and compliance audits of suppliers including external manufacturers. Supports the maintenance of the approved supplier list.
• Develops and deploys strategies for talent attraction, development, and retention to enhance the talent pipeline.
• Champions cross-franchise and sector assignments to foster global leadership development. Essential Duties and Responsibilities (Other duties may be assigned):
• Assures that the supplier quality system audit function complies with QSR/GMP, ISO and other regulatory requirements.
• Performs audits of suppliers for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
• Performs supplier re-audits of deficient matters and corrective actions, as needed and required.
• Assigns classifications and documents supplier audit results in written audit reports that are distributed and reviewed by appropriate management.
• Monitors the effectiveness of supplier corrective action responses.
• Serve as lead auditor, leading a team of auditors, technical experts, auditors-in training and/or volunteer auditors.
• Maintains reports of supplier audits, re-audits and corrective action responses.
• Provides direction and guidance to supplier auditors.
• Collects and reviews supplier audit metrics and communicates to site and worldwide management. Generates data for management reviews.
• Assists in formulating & implementing supplier procedure improvements to be followed by the supplier auditors.
• Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
• Responsible for following all company requirements related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Submits and manages budget schedules and employee performance standard

Period of Employment: May 2002 – Sep 2012 (10 Years and 5 months)

Name of Employer: ITL Asia Pacific Sdn. Bhd. (currently known ITL Biomedical) Business Address: Persiaran Perindustrian Pengkalan 29A, Taman Perindustrian Pengkalan Maju, 31500 Lahat, Perak, Malaysia

Position Held: QA/RA Senior Manager

Responsibilities/Areas of Expertise

A. Dec 2007 – Sep 2012 - QA/RA Senior Manager

• Responsible to recommend and implementation of policies, objectives and strategies, including short and long term plans of the company quality system in compliance to ISO 13485, ISO 14001 EMS and FDA 21 CFR 820 Quality System Regulations with the view to maximize the Quality Assurance, Regulatory and Environmental system objectives in assuring the safety and effectiveness of the company’s procedures.
• Participate in management decisions on the company’s Quality Assurance, Regulatory Affairs, Environmental systems, policies and practices within the entities of ITL Group of Companies.
• Formulate and fully in-charge of a system for the recording, evaluation and processing of customers complaints on product quality.
• Implement specifications for the systems of control, inspection, sampling and test procedures with defined acceptance and rejection limits, including the control of all quality system documentation.
• Responsible to oversee that the company compliance with legal and voluntary quality and environmental standards and maintain continued certification of the quality and environmental systems implemented by the company. Constantly aware of any regulations and regulatory requirements introduced / amended on standards / systems affecting the company’s products / environments and ensuring the company compliance with such changes.
• Responsible in Quality System audit – Internal Quality Audit (IQA) and Supplier Quality Audit (SQA) in accordance to ISO13485:2003, FDA 21 CFR 820 Quality System Regulations and MDD requirements.
• Development and maintaining Risk Management File according to ISO 14971-2009 for all CE mark products. Kay person on maintaining and review Risk Management File during management review.
• To ensure and monitor that all the critical components purchased and medical devices produced by ITL Asia Pacific Sdn. Bhd. are in compliance to ISO109931:2009 requirement.
• Responsible in monitoring the Implementation of Total Product Life Cycle in the company.
• Monitor product quality by enforcing good control of processes and implementation of quality system in the manufacturing to ensure full compliance to specifications includes: a) Application of SPC techniques to process validation b) Vendor control and qualification activities c) Lead and co-ordinate company self-audit program (Internal Quality Audit) d) Liaison in all matters relating to product / environmental complaints, government inspections and other regulatory activities. e) Act as the primary liaison with regulatory consultants, representatives of regulatory agencies and Notified Bodies f) Ensure all relevant regulations applicable are observed in the course of design, manufacturing and post market surveillance processes,
• Responsible as Quality Management Representative (QMR)

B. Dec 2003 - Dec 2007 - Technical Manager - Research & Development

Responsibilities/Areas of Expertise

• Responsible to manage research and development work and related activities for ITL Asia Pacific Sdn. Bhd. in effective manner and meet the ISO13485:2003 and FDA 21 CFR 820 Quality System Regulations requirements.
• Responsible for Project Management in the company for process and technology transfer to ITL’s manufacturing facilities.
• Responsible to review the products produced meet the state of the art quality and regulatory standard and international requirement. (i.e. ISO, EN, GHTF, MDD, FDA QSR)
• Responsible for new product development (NPD) for the company to established in an effective manner and compliance to state of the art standard and regulatory as well as meeting customer requirement.
• Responsible for development and maintenance of Design and Development Control of all products being developed in the company.
• Responsible for development and maintenance of Design History Files according to ISO13485;2003 and FDA QSR requirements of all product developed by the company.
• Responsible for managing and coordinating USFDA 510K submission for all the products required to be marketed to United State.
• Responsible for development and maintenance of Technical File and Design Dossier according to MDD requirement of all product developed by the company
• Responsible for managing OEM (Original Equipment Manufacturing) product development, costing, documentation and production transfer in an effective manner and compliance to the state of the art standard and regulatory and meeting customer requirement and timeline.
• Manage and conduct the testing of materials, products and devices to ensure compliance with state of the art standard and customer requirements
• Evaluate and establish process parameters, process flow and line balancing for new products • Responsible for supplier selection, qualification and approval process system and lead a team for Supplier Audit and Monitoring program for new material or components.
• Assist Tool Makers and designers to ensure that new tools are fabricated, qualified and validated according to the medical device regulatory requirements.
• Responsible in managing the pilot run production (manufacturing) for new developed products, OEM products and products for clinical trial in the effective manner and meeting all the required standards and specification.
• Implement specifications for the systems of control, inspection, and sampling and test procedures with defined acceptance and rejection limits, including the control of all documents thereof for the pilot run manufacturing.
• Managing the technical issues related to Manufacturing processes, Product Specifications, and Product and QA Technical Drawings. • Managing plant wide process improvement and trouble-shooting exercise.
• Organizing the installation, qualification process and line balancing of new products manufacturing and related equipments to be used to manufacture disposable medical device prior mass production.

C. May 2002 - Dec 2003 – Assistant R&D Manager

Responsibilities/Areas of Expertise

• Undertake project management and product development responsibilities in an effective manner, and ensure that outcomes are of high quality and delivered within budget and in a timely manner.
• Assist with the production, assembly, packing, testing and approval of all samples and pre-production products and device
• Assist with training of Production and other staff with respect to new products and devices
• Assist with the fabrication of prototype and rapid prototype devices, parts and tools
• Assist Tooling Department and designers to ensure that new tools are fabricated validated and tested to ensure compliance with Design requirements.
• Establish test methods/protocols for new equipment/material
• Manage and conduct the testing of products and devices to ensure compliance with customer requirements
• Evaluate and establish process parameters/flow for new products
• Perform sourcing for new material or components
• Prepare project costing and budgeting • Assist with providing information for quotation of OEM and other products and devices
• Establish related documentation for new products in accordance to ISO 9001 and FDA standards
• Assist in all issues relating to Specification Drawings and QA Drawings, including their control, updating and distribution
• Submit reports and updates as and when required to R&D Managers

Period of Employment: May 1994 - Apr 2002 (8 Years)

Name of Employer: Euromedical (Maersk Medical) Industries Sdn. Bhd. Business Address: Kawasan Perindustrian Bakar Arang 08000 Sungai Petani, Kedah, Malaysia Last Position Held: Product Development Engineer

A. Sep 2001 - Apr 2002 - Product Development Engineer

Responsibilities/Areas of Expertise

• Responsible for all new product and development process at Euromedical Industries Sdn Bhd and Maersk Medical Sdn Bhd.
• Responsible for process validation, clean-room validation, packaging validation and sterilization validation • Sourcing of new materials and technology related to the new product being developed.
• Establish method for product and material testing compliance to the current international and local standard which meet customer requirement.
• Conducting new material qualification and product performance testing for all new products development.
• Research and development work on the new process and technology related to the new product development
• Liaise with external and internal vendors for development of production equipment and testing equipment for product and research and development work.
• Conduct product and process training to key personnel (Q/QC, production, engineering, maintenance) on the new product.

B. Aug 1999 - Sep 2001 - QA/R&D Microbiologist

Responsibilities/Areas of Expertise

• Monitoring microbiological work in order to meet medical devices requirement (MDD and FDA)
• Conduct environmental and microbiological monitoring of the clean room facilities and laboratories meeting medical devices manufacturing standard and international standards.
• Organizing chemical and biological compatibility testing according to USP and ISO 10993 requirement.
• Monitoring Ethylene Oxide (EtO) sterilization process for Sungai Petani and Kulim plants.
• Monitoring of Control and release of sterile medical devices for EtO and Gamma sterilization.
• Responsible for the sterility of sterile finished products produced by the company are meeting all standards and requirement.
• Monitoring the Pyrogen (Endotoxin) testing for all pyrogen free products.
• Monitoring bioburden Test and Latex Protein Test.
• Responsible for calibration process of all measuring equipment, process equipment and sterilization chamber.

C. May 1994 - Aug 1999 - Product Development Chemist - R&D

Responsibilities/Areas of Expertise

• New product development, line extension and product/design change or improvement for EISB
• Conduct training and technical assistant to key personnel on new product development
• New materials and components sourcing and qualification
• Material and process evaluation for all the product under development
• Establish testing methodology and process control for all new product being developed
• To conduct process and equipment validation exercise.
• Monitoring and implementing statistical process control and six-sigma on the new product manufacturing.
• Reason for leaving: Enticed by the R&D Manager role

Diploma in Biology

Major: Microbiology

University Technology Mara (UiTM) Shah Alam, Malaysia (Institut Teknologi Mara)

Graduation date: July 1992