Find an Expert
Expert in Supplier Quality Assurance, Cost Improvement Projects, ISO 9001:2000 Quality Systems Management
- Expert audited suppliers to conformance with expected standards, such as TS 16949:2002 or ISO 9001:2000. An ISO standards based checklist was used; this provided quantitative scores for each category. Objective evidence and comments were compiled as the audits progressed.…
Expert in Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Expert in Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Expert in Consumer Product Safety, Regulatory and Retail Compliance, Quality Assurance
Expert is a consumer product (non-food) safety, regulatory and retail compliance, quality assurance and control, 3rd party lab testing / inspection / auditing, CPSC (Consumer Product Safety Commission), CPSIA (Consumer Product Safety Improvement Act), Federal / State / Local compliance…
Expert in Nuclear Quality
Looking for a professional Project/Program Manager, Quality Control Specialist or a nuclear industry consultant with extensive expertise in operations, site development, start-up and commissioning, reactor refurbishment, refueling, decommissioning, quality assurance, quality control, facility evaluation and program assessment? Then we should…
Expert in Food Safety and Quality
Expert is a professional food safety consultant and auditor who has been registered with SQF (the Safe Quality Food Institute) as such. He has accrued vast experience implementing food safety and quality assurance compliance systems for top-tier food manufacturing firms.…
Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Expert in Program Management, Quality Systems, Strategic Improvement Initiatives, Quality Assurance
During the 20 years professional life, Expert held a variety of global positions of increasing responsibility in all aspects of program and quality management including Portfolio management, New Product Introduction program management, Strategic Planning, Development on new product introduction methodology,…
Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s
Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…