Mohammed Yassien

Contract Manufacturer for Medtronic | PCB & PCB Assembly Expert Spearhead the development, implementation, and continuous auditing of integrated Quality Management Systems (QMS) compliant with ISO 13485, ISO 14001, and AS 9100 standards, ensuring adherence to global quality, safety, and environmental regulations. Direct the Corrective and Preventive Actions (CAPA) system, identifying root causes of non-conformities and driving robust solutions to enhance process efficiency and product quality. Execute comprehensive supplier audits and evaluations, ensuring raw materials, packaging, and finished products meet rigorous quality benchmarks while leading the vendor qualification process to align with industry standards. Oversee regulatory submissions, including license variations, renewals, and product registrations, while maintaining close collaboration with Competent Authorities to ensure timely approvals and compliance with global regulations. Provide strategic guidance to senior leadership on regulatory requirements and quality strategies, supporting the development and market introduction of new products while ensuring compliance with all relevant regulations. Ensure all employees are trained on the latest QMS updates and Standard Operating Procedures (SOPs), fostering a proactive quality culture across the organization. Lead cross-functional coordination to elevate overall quality performance, optimizing labeling, packaging, and storage protocols in compliance with industry regulations and customer specifications.

Spearheaded the design, implementation, and ongoing auditing of an ISO 13485-compliant Quality Management System (QMS), ensuring alignment with international regulatory standards and driving continuous quality improvement initiatives across all operations. Established and managed a robust Corrective and Preventive Action (CAPA) system, facilitating the identification, investigation, and resolution of non-conformities while ensuring compliance with quality and regulatory frameworks. Authored, reviewed, and submitted comprehensive technical documentation for CE mark approvals, coordinating with notified bodies to ensure seamless product certification and market entry. Conducted rigorous supplier evaluations and vendor qualifications, overseeing quality assurance processes for raw materials, packaging components, and finished products to ensure compliance with regulatory and industry-specific standards. Directed regulatory submissions, including license variations, renewals, and product registrations, ensuring adherence to strict timelines and regulatory requirements across multiple jurisdictions while maintaining effective communication with Competent Authorities. Led cross-functional training initiatives on QMS and regulatory standards, ensuring all employees were up to date on the latest ISO, ASTM, and other relevant standards, and continuously improved internal SOPs to meet evolving regulatory demands. Provided expert strategic regulatory counsel to senior management throughout the product development lifecycle, ensuring products met all regulatory requirements from design through commercialization, while overseeing quality inspections, safety coordination, batch release, and packaging/labeling compliance with global standards.

Built strategic relationships with the Local Content & Government Procurement Authority (LCGPA) and successfully secured the company’s qualification in NUPCO and SABIC’s NUSANED program, enhancing market positioning and expanding business opportunities. Oversaw end-to-end operations at the manufacturing site, including procurement, supply chain, logistics, injection molding, assembly, packaging, sterilization, and product delivery. Served as the designated Management Representative during quality audits, ensuring quality assurance and operational efficiency. Established and led the implementation of a comprehensive Quality Management System (QMS), achieving ISO 13485:2016 certification and ensuring compliance with global medical device manufacturing standards. Directed the qualification and validation processes for Clean Rooms and Ethylene Oxide sterilization systems, ensuring regulatory compliance and operational excellence in manufacturing environments. Developed and compiled the Technical File, successfully achieving CE Mark certification and ensuring regulatory compliance for product commercialization across international markets. Ensured full adherence to Saudi FDA regulations, resulting in the successful acquisition of critical Medical Device Establishment License (MDEL) and Medical Device Marketing Authorization (MDMA) approvals, facilitating seamless market access.

Led all branch operations, including procurement, supply chain, logistics, sales, and marketing, ensuring the achievement of monthly, quarterly, and yearly sales targets while maintaining high customer satisfaction through consistent monitoring and employee performance evaluations. Registered international manufacturers and their medical devices with the Saudi FDA and Gulf Ministries of Health, ensuring strict compliance with medical device regulations. Stayed updated with international legislation to ensure timely and accurate registration and compliance for all products. Developed regulatory strategies for new product licenses, license renewals, and variations, establishing clear timelines and managing negotiations with regulatory authorities to secure marketing authorizations, ensuring products were approved within required timelines. Directed the implementation and maintenance of ISO 9001 standards across all facilities, conducting internal audits to assess compliance with quality management systems, and ensuring consistent application of the Quality Manual and Standard Operating Procedures (SOPs). Oversaw quality and regulatory inspections, reviewed company practices, and advised on necessary system changes to align with regulatory and quality requirements, ensuring all operations adhered to local and international standards. Evaluated and selected suppliers for finished products, ensuring they met stringent quality standards and regulatory requirements while driving continuous improvements in supplier performance and maintaining the highest standards of product quality and safety.

Led regulatory submissions and ensured product compliance with Competent Authorities, including CE mark approvals for Class I, IIa, IIb, and III medical devices. Provided strategic regulatory advice throughout the product development lifecycle, negotiating with regulatory bodies to secure marketing authorizations. Developed and reviewed comprehensive Technical Files, product labels, and Standard Operating Procedures (SOPs), ensuring alignment with the latest industry standards such as ISO 9001, ISO 13485, ASTM, and other relevant regulations. Regularly updated documentation to meet evolving regulatory requirements. Conducted internal audits across company facilities, coordinated ISO 9001 and ISO 13485 certification processes, and implemented a robust Quality Management System (QMS) through the creation and enforcement of a Quality Manual and Quality Policy. Managed cross-functional teams in the development of new products, overseeing project timelines and regulatory inspections while liaising with regulatory authorities to ensure timely license variations, renewals, and approvals. Evaluated and approved suppliers of raw materials, packaging, bulk, and finished products, ensuring compliance with internal and external quality standards. Monitored microbiological laboratory activities, water treatment processes, and overall product safety. Led company-wide training on regulatory requirements and SOP adherence, improving organizational compliance. Spearheaded initiatives to enhance quality levels, ensured the availability of updated standards, and drove continuous improvement efforts across departments.