MENTOR DOCUMENTS AND CONSULTING LLC
Summary
Federal & State Regulation compliance, Project management, Technical Writing, Statistical Analysis, Spanish, SOP Management, Medical Device, Validation, Instrumentation, CFR Documentation Practices, AS 9100; ISO900, EASA; CASE, CAPA Management, training, Quality Assurance, Quality Management, Quality Control, Deviation Investigations, ANSI ASHRAE Standard 188, 42 CFR 482.42, Facility Facilities Compliance, Risk Assessment, Legionnaires prevention, Legionella prevention
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Description
We are seasoned professionals ready to effect regulatory compliance, auditing and implementation across an organization. Our key performers have Kaizen, International Standards Organization (ISO), Six Sigma, American Standard of Quality training and certifications. Our diverse experience has been our best teacher. Background includes Regulatory Compliance, Quality Management (Research and Development, Manufacturing, Quality Management), managing FDA and European entity operational licensing and providing Quality Performance Reviews for Medical Device (Manufacturing FDA licensing and ISO Certification), and the Oilfield Industry (Chemistry laboratory openings, closures, training and management). Our experience includes leading teams in decommissioning oilfield laboratories, design engineering for new laboratory structures and instrument procurement. Training, Quality Assurance, Statistical Analysis, Metrics, Quality Control. Pharmaceutical Remediation
