Bryon Bailly Email & Phone Number

Quality Assurance/ professional with over 25 years experience in manufacturing and service industries. Experience in compliance to regulations and standards such as US FDA, i.e. 820 (devices), Part 11 (electronic signatures), ISO 9001, ISO 13485 (medical devices). Services that I can provide are training in general quality management, quality application tools, and auditing. I can guide the company through regulatory inspections and registrar audits as well as the preparation of responses and corrective action follow through. I have also helped facilities complete their qualification setup and completions (IQ/OQ/PQ) and have set up and managed document control systems and complaint handling systems including MDR submissions.Specialties: Quality Management System development, improvement, consulting, training, auditing, FDA 820/1271, ISO 9001/13485American Society of Quality’s Certified Quality Auditor (CQA)

Listed skills include Quality System, Fda, Quality Assurance, Quality Management, and 20 others.

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  Ashford University

  Organizational Management