Beruflich Dokumente
Kultur Dokumente
- Risk Management Plan - Risk Analysis (Intended Use, Identification of Hazards, Estimation of Risks - Risk Evaluation - Risk Control (Risk Control Option Analysis, Implementation of Risk Control Measure(s), Risk/benefits analysis - Evaluation of overall residual risk acceptability - Risk Management Report - Production & post-production information.
- R&D Engineers / Managers - Quality Assurance Personnel - Regulatory Affairs Personnel - Advanced Manufacturing Personnel - Manufacturing /Operations Personnel - Consultants - Quality System Auditors
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OUR SPEAKERS:
Over fifteen years of Product Development, Quality Engineering & Management experience for Medical Devices (PMA & 510K Implants & Instruments) and Automotive Components. People/function management experience including performance management, development plan, resource plan, budgeting and control. Experienced in Product Development, Design Control, and compliance to CFR 820.30 including VOC, User Needs, Design Inputs, Design Verification & Validation and Design Transfer. MBA, MS (Manufacturing Engineering), BS (Mechanical Engineering). ASQ Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE) & Certified Reliability Engineer (CRE). Experienced in Risk Management (ISO 14971), Project Management, FDA Audits & Process Validation (IQ/OQ/PQ), Supplier Qualification, CAPAs. Worked as assistant coach for Dale Carnegie Training Institute for Communications Skills Experienced in working with multi-national teams including from Europe & Asia. Specialties:Product Development, Design Control, Risk Management, Reliability Engineering, Six Sigma, Statistics, Process Validation