Al Young
About Al Young
Al Young is a Senior Director of Quality Assurance with over 20 years of experience in the medical device industry, specializing in regulatory compliance and quality systems for Class II and III devices.
Education and Expertise of Al Young
Al Young is an ASQ Certified Professional in Quality and Reliability Engineering, emphasizing his extensive qualifications in the field of quality assurance. With over 20 years of experience, Al Young has dedicated his career to the medical device industry, specializing in ensuring that products meet rigorous regulatory standards. His expertise is rooted in his comprehensive understanding of both US and international market regulations.
Professional Background of Al Young
Al Young has built a significant career in quality assurance, with roles spanning from Quality Engineer to Senior Director in small to medium size medical device companies. His experience includes working under prominent corporations like Johnson & Johnson, Medtronic, Covidien, and iCAD. This diverse professional background demonstrates his ability to adapt and lead in various organizational settings while maintaining high standards for product quality and regulatory compliance.
Roles and Responsibilities as Senior Director of Quality Assurance
As the Senior Director of Quality Assurance, Al Young has been instrumental in establishing, improving, and maintaining quality assurance programs and systems. His work ensures compliance with ISO 13485, the FDA Quality System Regulations, and EU regulations. His role involves overseeing the quality assurance processes for Class II and Class III medical devices, ensuring these products meet the necessary standards for commercialization in both US and international markets.
Achievements in Quality Assurance
Throughout his career, Al Young has significantly contributed to the medical device industry by supporting the successful commercial launch of new products. His achievements include developing and refining quality assurance programs that align with industry regulations, contributing to the compliance and market readiness of various medical devices. These efforts have ensured that products meet critical safety and efficacy standards required for market entry.