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Online Resumes with "FDA 21 CFR"
Architect - 11 Years of Experience - Near 08817
PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...
Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script
Business Analyst - 7 Years of Experience - Near 08817
Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...
Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project
Team Leader - 9 Years of Experience - Near 08854
Experience Summary * A seasoned analytics and consulting professional with ~9 years of industry experience as a SAS Consultant and Business Data Analyst with a strong understanding of Data Handling and Management, SAS, Project management, and Business Analysis. Project Summary This program supports the in-out of the company's innovative value-based programs. This includes the analyses of business KPIs and financial metrics ...
Tags for this Online Resume: Programming, Support, ETL, QA, Management, Data Extraction, Project Management, Requirements Analysis, SAS, Data Analyst
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Quality Assurance Specialist - 14 Years of Experience - Near 34685
Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...
Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall
Mechanical Engineer - 19 Years of Experience - Near 45039
SUMMARY * Strong expertise in System Engineering, Mechanical design, FEA & Vibration testing * 19 years of industry experience in product development and project management * Medical device design experience familiar with ISO13485 and FDA 21 CFR 820 Standards * Extensive knowledge of electro-mechanical, fluid mechanics and heat transfer * High-level in multitasking using communication, presentation, and management skills * ...
Tags for this Online Resume: Management, Project Management, System design, Systems Engineer, HVAC, Engineering, MEMS, Research, Instrumentation, Legacy
Quality Manager - 20 Years of Experience - Near 28269
Summary of Qualifications and Accomplishments * Demonstrated excellent Quality Management/ Engineering work experience, providing technical support to customers, suppliers, cross-functional team members, and manufacturing on new and existing products. * Knowledgeable and experienced with SMT, PTH, Hybrid, Chip on Board, Power Supply, and Fiber Optic technologies to assemble, test, and box build printed circuit boards in sup...
Tags for this Online Resume: ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering, ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering
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
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Quality Assurance Specialist - 13 Years of Experience - Near 08540
Professional Summary More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis Data Analysis and Management Software Application Testing Document Management Change Control and Release Management FDA Compliance Verification and Validation Quality Assurance Processes and Methodologies Developing Testing Strategies and Test Plans Test Scenarios and executing ...
Tags for this Online Resume: Test Scripts, Test, Management, Test Cases, Structured Query Language, Audit, CFR Part 11, Test Plan, Application Server, Documentation, validation of protocols
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
