![]() ![]() Her experience includes program management and project management of global, third-party, and notified body certifications for the medical industry. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.Īshley Kelleher - Ashley has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. She has been involved with writing quality procedures developing supplier, internal and corporate audit programs developing quality management systems and developing and presenting quality-related training and seminars. Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. Her experience includes the development of pre‐clinical testing protocols and reports, risk documentation, quality system and regulatory affairs standard operating procedures, sales training materials, safety reports and domestic and international regulatory strategies and submissions. He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.ĭeborah Baker-Janis - Deborah Baker-Janis - Deborah joined NSF in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. Food Safety, Quality and Standards TrainingĬourse tutors selected from the following:.Circularity, Waste and Materials Management.Plastic and Plumbing Testing and R&D Lab Services.ISO/IEC 27001: Information Security Management.ISO/IEC 20000-1: International Service Management Standard.Cybersecurity Maturity Model Certification (CMMC).Water Treatment Products Testing and Certification Services.Dietary and Nutritional Supplements and Cosmetics and Personal Care Products.Virtual Kitchens, Mobile Kitchens, Aggregators and Food Innovators. ![]() Quick Service Restaurants, Restaurant Chains and Franchisees. ![]()
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