Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
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Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
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Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Professional Summary Experienced Manufacturing Engineer with Production Management and Product Development Engineering Experience. Started career in product development where I managed projects and cross functional teams eventually being promoted into engineering management. Later, as production manager, I managed a 30 million dollar manufacturing department and was responsible for maintaining all KPI's and providing engine...
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Manufacturing, Construction, Engineering, Enterprise Requirements Planning, Green Belt, Injection Molding, Kaizen, Layout, Lean Manufacturing, Management, project engineer, project manager, mechanical engineering, SOLIDWORKS, Medical Device, OQ IQ PQ, validation, product development, Tooling design, Fixture design, manager
