Muhammad Fahmy

Serving on the Advisory Council for the Customer Experience Certificate Program at Seton Hall University, Stillman School of Business. Contributing industry insight related to customer experience, organizational transformation, continuous improvement, and business strategy while supporting collaboration between academia and industry professionals.

Founder of Fahmy Consulting LLC, delivering end-to-end ISO certification, regulatory compliance, maritime consulting, and business transformation services. I help organizations build practical management systems, achieve audit readiness, and turn compliance into a competitive advantage.

● Head the Quality Assurance (QA), Quality Control (QC), and Process Development teams, focusing on medical device and Primary Packaging for drug delivery systems. ● Ensure full alignment with global regulatory standards including FDA, MDSAP, EU MDR, and ISO 13485, meeting customer requirements and industry norms. ● Develop and oversee regulatory compliance policies, training programs, and procedures specifically tailored to the medical device industry. ● Lead internal and external audits to affirm adherence to global regulations and industry standards. ● Serve as the key liaison for regulatory agencies, coordinating and participating in regulatory inspections. ● Stay abreast of changes in regulatory demands and industry standards, analyzing their impact on the company's products and processes. ● Cooperate with cross-functional teams to integrate compliance with regulations throughout the product design, development, and manufacturing stages. ● Resolve regulatory compliance concerns promptly and manage the development of continuous improvement initiatives to enhance regulatory compliance programs. ● Spearhead innovation projects to drive growth and improve medical device products and processes. ● Foster relationships with regulatory agencies, industry organizations, and stakeholders to maintain an up-to-date understanding of regulatory demands and industry trends. ● Coach and mentor team members in problem-solving and continuous improvement methodologies. ● Developed comprehensive costing and pricing models tailored to specific customer requirements, integrating cost analysis, regulatory compliance, and market dynamics to ensure competitive and compliant product pricing. ● Developed and implemented a robust system for monitoring bioburden on products, ensuring compliance with regulatory standards for product sterility and maintaining the highest levels of safety and quality in medical device manufacturing.

● Led Six Sigma projects, coaching Black and Green Belts on continuous improvement projects to optimize medical device production. ● Played a key role in the Executive Committee, aiding in strategic planning and setting departmental objectives. ● Mentored QA & QC Managers in setting and monitoring KPIs to meet department goals. ● Pioneered the Safety Committee, providing member training. ● Supported supply chain improvements and resilience projects, ensuring smooth global delivery of our medical device products. ● Worked closely with the Labs for ISO 17025 accreditation. ● Chaired the Sustainability and Social Responsibility Committee. ● Headed microbiology compliance, cleaning, and sterility projects critical for medical device safety. ● Managed Quality in multiple sites and the certification processes. ● Developed Sustainability program including FSC CoC compliance system and certified 100% FSC product.

- Conducted internal audits in line with ISO 9001, ISO 14001, and ISO 45001, leading Root Cause Analysis and Consultation in 8D and CAPA processes. - Led extensive training on Quality Management System, ISO requirements, Six Sigma, and Project Management, enhancing understanding and implementation. - Headed the Document Controllers and compliance team. - Directed the Process Qualification and Validation Process, including Installation Qualification (IQ), Measurement System Analysis (MSA), Process Design (PD), Operational Qualification (OQ), and Performance Qualification (PQ). - Responded to customer complaints and led Corrective and Preventive Actions (CAPA). - Led Design of Experiments (DOE) for new product development. - Maintained and updated the Quality Management System (QMS) to meet production, ISO, and regulatory requirements. - Led change management in products and processes using ISO 13485 guidelines and European MDR, ensuring smooth transition and adoption.

- Champion of ISO 9001 and IATF 16949 Internal Audits, setting audit plans and leading the internal audit team for compliance verification. - Head the development and implementation of Six Sigma Projects as a certified Six Sigma Master Black Belt, driving significant improvements in production processes. - Develop and deliver comprehensive training on the Quality Management System to plant management and supervisors, fostering a culture of quality consciousness. - Maintain and update the Quality Management System (QMS) in accordance with ISO 9001, ISO 14001, ISO 45001, IATF 16949, and changing customer and regulatory requirements.

- Consultation Team Leader: Steered the consultation teams in strategizing, decision-making, and problem-solving initiatives, focusing specifically on the medical device and pharmaceutical industry. Facilitated robust discussions on complex regulatory compliance, product quality, and process optimization issues. Employed a collaborative approach, leveraging diverse expertise to drive informed decisions and effective resolutions. Key responsibilities included advising on pharmaceutical dossier compliance, ensuring smooth submission and approval processes with global regulatory authorities, and enhancing overall performance in drug delivery system operations. - Process Improvement Team Leader: Orchestrated the initiatives of cross-functional teams dedicated to process enhancements within the medical device and pharmaceutical sector. Utilized comprehensive knowledge and expertise in Six Sigma methodologies, continuous improvement processes, and validation procedures. Implemented effective strategies, resulting in significant improvements in operational efficiency, product quality, and regulatory compliance. Championed the execution of Design of Experiments (DOE) for new product development, leading to increased innovation and excellence in drug delivery system solutions. - 2nd & 3rd party Lead Auditor: Directed a comprehensive range of audits, both internal and external, to ensure strict adherence to a variety of standards including ISO 9001, ISO 14001, ISO 45001, IATF 16949, ISO 13485 (Medical Devices), and Good Manufacturing Practice (GMP) for Pharmaceutical products. Demonstrated proficiency in various auditing styles, including system, process, and product audits, significantly bolstering the company's credibility and ensuring unyielding compliance.

(Marine services company specializing in offshore support, serving clients like Saudi Aramco and Port Authority) ● Developed and implemented a fully integrated ISO-based Integrated Management System (IMS) across the organization, aligning with marine, industrial, and regulatory standards. ● Successfully led the company through certification audits for ISO 9001, ISO 14001, ISO 45001, API Q2, and Certificate of Compliance (CoC)—achieving first-time certifications with zero major non-conformities. ● Acted as Designated Person Ashore (DPA) and Management Representative, responsible for ensuring compliance with ISM Code and bridging communication between vessel operations and top management. ● Led and managed internal audit programs, risk assessments, safety inspections, and compliance reporting across vessels and offices. ● Facilitated continual improvement initiatives using Six Sigma and Lean tools to enhance safety, environmental compliance, and operational efficiency. ● Oversaw implementation of emergency preparedness, HSE procedures, and incident investigation protocols, reducing reportable incidents by over 30%. ● Delivered training programs to onboard and shore-based personnel on QHSE awareness, risk management, and regulatory compliance.

- Maintaining and updating the Quality Management System (QMS) according to the industry standards and business requirements. - Executing HACCP (Hazard Analysis and Critical Control Point) audits, ensuring proper identification and control of hazards in food safety. - Leading internal audits, overseeing the review of processes, and facilitating improvements as necessary. - Spearheading Six Sigma projects for process improvement and organizational efficiency.

- vessel's safety - navigation - maintenance staff supervising - ISM \ ISPS

- Maintain and Update the QMS - HACCP Audits - Internal Audits - SIX SIGMA PROJECTS

Served as Ship Captain with comprehensive responsibility for the safe navigation, communication, and operational management of various vessel types. Led and ensured adherence to quality management systems, conducted safety audits and drills, and managed all documentation and reporting. Oversaw budgeting, inventory management, and crew training, ensuring optimal vessel performance and regulatory compliance.

Served as Chief Mate with key responsibilities for overseeing the day-to-day operations of the vessel, including navigation, safety management, and crew supervision. Managed communications, conducted safety drills and audits, and ensured compliance with quality standards. Led documentation processes, supported budget planning, and managed inventory to maintain efficient and safe vessel operations.

Pursuing an AACSB-accredited MBA at BU Questrom to complement 15+ years of regulatory compliance and quality leadership in medical device and pharmaceutical manufacturing. Coursework: strategy, finance, operations, business analytics, and leadership, building the financial acumen and strategic toolkit required for VP-level roles in Quality and Regulatory Affairs.

Course Objectives Upon completion of this course you should be better able to anticipate supply chain risks facing your community and collaborate with others to manage supply chain risk. Module 1: Understand key aspects of contemporary demand and supply networks including pull, push, and flow. Module 2: Understand resilient characteristics of contemporary demand and supply networks, including scale, diversity, distance, and self-organization. Module 3: Understand risk characteristics of contemporary demand and supply networks, including bottlenecks, decreased diversity, and reduced self-organization. Module 4: Understand catastrophic contexts for contemporary demand and supply networks, including demand volatility, inflexible supply capacity, and loss of flow. Module 5: Understand one practical, repeatable process for self-assessment of regional demand and supply networks.

Do we have skilled and richly diverse staff to serve our clients and our mission tomorrow? To plan our organizational future, we need tools, methods and a format for conversations that identify, foster and grow our talent. And, our plans need to ensure a talent base that reflects all aspects of diversity people, cultures and ideas.