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Online Resumes with "cfr"
Director of Quality - 20 Years of Experience - Near 75063
Accomplishments included significant reductions in customer complaints, up to 50% over 60% reduction of rework increase in percentage Right-First-Time, to reach RFT >99% recalls prevention reputable audit certifications plant readiness for audits. * Promoted from Quality Assurance Manager to Plant Manager after a few months in the company due to the immediate impact on the organization's transformation from an environment o...
Tags for this Online Resume: Compliance, Quality, Quality Assurance, Quality Control, Test, Audit, Complaints, Consulting, Defense, Internal Auditor, manufacturing, Director and consultant of food safety and quality
Project Manager - 15 Years of Experience - Near 27519
SUMMARY Senior Project Manager with 15 years of experience in managing IT projects for firms across U.S and Asia. Involved in managing client & vendor relationships, development and support teams working in global/virtual working environment with onshore, offshore and multi-location delivery models. PMP Certified Practitioner aiming to leverage my considerable experience and efficiency expertise into your project manager ro...
Tags for this Online Resume: Management, Support, Acquisitions, CFR Part 11, Data Management, Integrate, Itil, Legacy, Manufacturing, Planning, agile, java
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
Quality Manager - 12 Years of Experience - Near 19120
I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...
Tags for this Online Resume: Documentation, Manufacturing, Integrate, Oracle, Graphical User Interface, Intranet, Microsoft Visio, Microsoft Visio Professional, Microsoft Word, Statistical Analysis, Technical Writer, Documentum, Sharepoint, Trackwise
Industrial Engineer - 15 Years of Experience - Near 06422
SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...
Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,
Clinical Quality Assurance - 20 Years of Experience - Near 46360
Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...
Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance
Quality Engineer - 13 Years of Experience - Near 92630
I enjoy working with start-up or multi national/ global medical device companies. Apply my experience in mechanical engineering to design & development, remediation projects for class II medical devices.
Tags for this Online Resume: Product Development, Manufacturing, Medical Devices, Product Design, Training, Documentation, Packaging, Test, "project management", production, mechanical engineer, Project Engineer, USFDA 21 CFR (QSR), ISO 13485 (QSR), ISO 14971 (Risk Mngt), MDD/93/42/EEC, QA Engineering, Contract Eng. Start-up & Multi National/Global
Quality Assurance Specialist - 7 Years of Experience - Near 75093
Professional SUMMARY * Over all 7 years of experience in the IT industry in Quality Assurance using Web based and Client/Server applications. * Knowledge of Healthcare, Pharma, Security and Biometric projects. * Key expertise includes testing Extensive experience in Manual and Automated testing using Selenium and defect tracking tools like HP Quality Center (ALM/QC), Bugzilla, JIRA and Bug Zero. * Conversant with all phases...
Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server
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
Engineering Technician - 20 Years of Experience - Near 77095
I am a team player who contributes to the organization with his 20 year knowledge in the Data interpretation of In-line Inspection (ILI) data and how it relates to Pipeline Integrity.
Ideal Companies: Preference is towards a company located near Zip code 77095.
Tags for this Online Resume: Global Positioning System, Support, Pipeline Integrity, Asset Integrity, DOT 192 and 195, In-line Inspection (ILI), MAOP Validation / Confirmation, Pipeline Records for TVC
Quality Manager - 4 Years of Experience - Near 23851
Professional Summary Bio Medical Director of Operations with experience in non-profit management, marketing, training and strategic planning. Proven track record of significant contribution to productivity levels by implementing, training and motivating successful teams. Effective leader with talent for building multi-functional teams while facilitating change management. Experience with compliance and standard operating pr...
Tags for this Online Resume: Budgeting, Operating Budget, Planning, Production Planning, Policies and Procedures, Deposits, Disaster Recovery, Inventory, Medical, HYGIENE
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
