Dan Clement
Staff Quality Assurance Engineer at Thermo Fisher Scientific
Based in San Marcos, United States
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Seniority
Staff
Department
Information Technology
Location
San Marcos
Industry
Biotechnology Research
Company size
99K
Contact information
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d•••••••@thermofisher.com
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Background
About Dan Clement
A knowledgeable professional with diverse experience in the areas of 21 CFR Part 820 Software Quality Control, 21 CFR Part 11, 210, 211, Annex 11, ISO 13485:2016, 14971:2012, 9001:2015 IEC 62304 Medical Device Software, IEC 60601 Medical Design Standards, Internal Audits, Operations, IT, and Logistics experience in the pharmaceutical, medical device, life science, and telecommunications industry. Key strengths include: Process Improvement, Communication, Problem Resolution and the ability to apply technology and processes to improve operational practices. Specialties: • Equipment Qualifications • Computer Systems Validation • Change Management, SOP Creation • Requirements Guidance and Review for projects. • Software development processes applied at a project level. • Risk management activities for programmable medical system development • Quality Assurance for planning, design, and production process development activities • Process improvement activities to ensure compliance with FDA/ ISO/ IEC regulations
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