Amer Ali

Detail-oriented Business Analyst and Mechanical/Quality Engineer with 3+ years of experience in the medical device manufacturing industry. Proven expertise in root cause analysis, quality systems, and regulatory compliance, including CAPA, 5 Whys, Fishbone Diagrams, and change control. Skilled in driving continuous improvement initiatives, supporting validation activities (IQ, OQ, PQ), and ensuring adherence to FDA and ISO standards. Adept at cross-functional collaboration, gathering and analyzing business requirements, and delivering actionable insights to enhance process efficiency and product quality. Strong background in mechanical design and documentation with hands-on proficiency in AutoCAD, CREO, and Pro-E.

• Performed statistical analysis techniques such as SPC (Statistical Process Control) and FMEA (Failure Mode and Effects Analysis) to drive process improvements and risk reduction.
• Evaluated the impact of CAPA implementation on overall medical product quality, contributing to the continuous improvement of manufacturing processes.
• Performed IQ/OQ/PQ validation activities and supported the introduction of new products into manufacturing line.
• Worked on implementation of product transfers and process modifications via process validation, test protocols and test reports for medical devices, create all documentation related to process (PFMEA, Visual Aids, Manufacturing Procedures), developed fixtures and tooling.
• Conducted data analysis to evaluate supplier performance, ensuring compliance with FDA regulations and industry standards to maintain product quality and safety.
• Integrated MS Office tools to create detailed supplier audit reports, ensuring clear documentation and actionable insights for continuous improvement initiatives.
• Ensured that all device master record (DMR) documentation complies with regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485. Regularly review and update documentation to reflect changes in product design, manufacturing processes, and quality standards.
• Utilized AutoCAD and other design tools to review and update bed equipment schematics, ensuring accuracy and alignment with regulatory requirements.

Master's in Industrial Management
Bachelor's in Mechanical Engineering