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Online Resumes with "Part 820"
Quality Professional
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
Quality Engineer
Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...
Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis
Quality Engineer
ACCOMPLISHMENTS & ACHIEVEMENTS * Researched and budgeted for a vast array of new soldering tips and equipment, microscopes, and specialized lens accessories, and a CMM in order to significantly improve inspection results. Automated SPC measurement systems that resulted in real-time data collection cost savings of $480,000. * Champion of lean six sigma and continuous improvement techniques within Kaizen culture. Became subje...
Tags for this Online Resume: Audit, Legacy, ISO, Management, Procurement, Quality, Quality Assurance, Quality Management, Test, Compliance
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
Quality Manager - 20 Years of Experience - Near 37064
Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...
Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions
Quality Assurance Specialist - 20 Years of Experience
Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....
Tags for this Online Resume: Data Analysis, Medical, Complaints, Quality, Risk Analysis
Not Listed - 17 Years of Experience - Near 53562
Areas of Expertise * Quality Engineer * Non-Conformance * Auditing * Product Surveillance * Training & Staff Development * Medical Device & Pharma * Complaint Review * Policy & Procedures * FDA/MDR Reporting * Subject Matter Expert * Complaint Investigation * 21CFR Part 210 and 211 * 21CFR Part 820 and 803 * ISO 9001, 13485 & 14001 * Laboratory Testing * Calibration and Validation * Federal Compliance * International Compli...
Tags for this Online Resume: Quality, Quality Assurance, Systems Operations, Documentation, Instrument Calibration, Notebook Computer, Project Coordinator, Process Improvement, Typing, Inventory, human resources
Production Manager - 20 Years of Experience - Near 01702
Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...
Tags for this Online Resume: Lean Manufacturing, Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical, Purchasing, Quality Assurance, manufacturing
validation/quality/manufacturing engineer
PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...
Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing
Director of Quality
Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12 of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, project-management and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...
Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management
Director of Quality
Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12+ of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, Project Management (MS-Project) and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, Supplier Management a...
Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management
Production Supervisor
Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...
Tags for this Online Resume: manufacturing, reliability, production, Lean Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical
