Wayne Fields
CTO & Quality-regulatory Director at Thermogear Inc
Based in Portland, United States
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Seniority
Other
Department
Other
Location
Portland
Industry
Appliances; Electrical; and Electronics Manufacturing
Company size
1
Contact information
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w•••••••@thermogear.com
Phone
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Background
About Wayne Fields
PROFESSIONAL EXPERIENCE Broad functions in product/program development/management; medical device Regulatory Affairs and Quality Assurance. GOALS domestic employment, consultation or contract arrangements centered on one or more of the Specialties listed below- Program/Function design, development, implementation & management - Regulatory Affairs & Quality Assurance - Quality Management Systems (product/regulatory affairs/quality)- Risk Analysis (dFMEA; ISO 14971)- Technical File (e.g. overall structure & all individual elements)- 510(k)s and ISO 13485 Certification; CE Mark: CSA/UL Mark Empowered writing, communications, task conduct, and management skills.
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