Fuad Mak Email & Phone Number

Education and Experience: • BA/BS degree in Engineering • 20 years of experience in Quality Assurance. • 13 years of experience in Quality Assurance Management.Specialization in Medical Device and Biotechnology: • Extensive experience in the medical device and biotechnology industry. • Significant focus on software testing, test automation, quality management, and regulatory compliance.Quality Assurance Expertise: • Proficient in developing and executing comprehensive quality assurance strategies. • Skilled in both manual and automated testing methodologies. • Expertise in QA methodologies, process improvement, and ensuring product quality.Regulatory Compliance: • In-depth knowledge of Quality Management Systems (QMS) and ISO 13485 compliance. • Well-versed in cGMP regulations, FDA/EU guidance, 21 CFR Part 11, Annex 11, and Data Integrity. • Extensive understanding of GAMP5 guidelines and best practices.Leadership and Management Skills: • Demonstrated leadership skills in managing a QA team. • Effective in developing and implementing QMS procedures. • Experience in conducting internal and external audits, and managing the CAPA process.Technical and Operational Skills: • Hands-on experience with QMS management software. • Ability to work both independently and collaboratively in dynamic environments. • Strong attention to detail and commitment to procedural adherence.Communication and Supervisory Skills: • Excellent communication, collaboration, and leadership abilities. • Proven supervisory and organizational skills, guiding teams and projects to successful outcomes.

Listed skills include Quality Assurance, Software Quality Assurance, Sql, Quality Center, and 46 others.

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  Moscow State Automobile And Road Technical Institute (State Technical University) (Madi)