Wil Gutierrez
Principal Consultant @Medical Engineering Consultants (MEC)
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WORK HISTORY
Principal Consultant @Medical Engineering Consultants (MEC)
Supporting CSV activities related to combo medical device. Modifying current manufacturing process and equipment to incorporate COTS and custom applications for controlling real-time data collection, and enhance ALCOA capabilities during Production.
EDUCATION
Campbell University
Associates Degree, General
University of Phoenix
B.S., Business and Information System
SKILLS
ABOUT WIL GUTIERREZ
Life Sciences professional specializing in quality assurance, validation, computerized systems, electronic data management, and regulatory compliance.Broad knowledge of the enterprise including: new product development; production/manufacturing; facilities; document control; laboratory and process automation; materials handling; IT infrastructure; corrective and preventative action (CAPA); complaint handling; auditing.Experience spans in-vitro diagnostics, medical device, pharmaceutical, genomics, and MRO/CRO.Pragmatic application of the requirements and best-practice presented in the following standards, guidelines, and regulations:ISO 13485:2003 and 14•••21 CFR Parts 11, 210, 211, and 820IEC 62304ANSI SW68GAMP 4/5MDD EU Annex 11, 15.Sarbanes-OxleyGDPR
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