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Online Resumes with "regulated environment"
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
Production Supervisor
PROFESSIONAL SUMMARY: Results-oriented, hands-on professional, with a successful record of accomplishments in manufacturing and production. Experience in industry, training, quality assurance and customer service with focus on providing the customer with the highest quality product, at the best price and on-time delivery. Major strengths include strong leadership, excellent communication skills, competent, strong team playe...
Tags for this Online Resume: Applications, Training, Automotive, Aerospace, CNC, Process Improvements, Scheduling, Quality, Quality Assurance
Clinical Quality Assurance - 7 Years of Experience - Near 92127
Summary Principal Quality Assurance Engineer with over 20 years of experience in both hardware and software quality engineering and compliance, with equal accomplishments in quality engineering and quality management. Extensive experience applying design controls to new product development of regulated class II Infusion and IVD medical device instrumentation, for electrical, mechanical, and embedded software driven medical ...
Tags for this Online Resume: Complaints, Instrumentation, Integrate, ISO, ISO 9001, Reliability, Audit, Chemistry, Compliance, Consumer Products
Not Listed - 18 Years of Experience - Near 14411
Summary High performing, goal oriented, Program/Project Manager with extensive experience in planning, scheduling, meeting deadlines, and life-cycle management in a regulated environment. Proven success in managing cross-functional teams, business analysis and improving efficiency to meet production and sales goals. I am a seasoned management professional who excels in establishing excellent working relationships with custo...
Tags for this Online Resume: Clarify, Microsoft, Microsoft Project, Planning, Product Development, Program Manager, Project Management, Project Manager, Research and Development, Risk Analysis
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Not Listed
CAREER FOCUS Combine military leadership and technical skills to identify, evaluate, and resolve problems with large-scale, complex operations, often within heavily regulated environments. Repeated success guiding highly skilled, cross- functional teams, able to build solid relationships with upper level executive leaders and achieve consensus across multiple organizational levels. Extensive experience with multimillion-dol...
Tags for this Online Resume: Inventory, Logistics, Cabling, Cisco, Install, Routers, Switches, Synectics Catalyst, Wireless, Team Lead
Business Systems Analyst
Summary Jim possesses excellent analytical and problem solving abilities with strong interpersonal and communication skills. Fifteen years of experience in developing and supporting GxP applications in highly regulated environments, provides him a clear understanding of how FDA and Quality Regulators, look at documentation and process controls. He brings accountability, integrity and a dedication to quality standards, to th...
Tags for this Online Resume: Budgeting, Integrate, Management, Planning, Quality, Quality Assurance, Quality Management, System Integration, Systems Analyst, Applications
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Engineering Manager - 20 Years of Experience - Near 19341
Profile * Dynamic New Product Development Engineering Manager and Program Manager with over 20 years leading global cross functional teams in the field of software applications and embedded real-time systems. * Trusted technical leader and a program management expert, mentoring on development best practices, project management, Agile, test driven development (TDD), test automation, process improvement, DFMEA and problem sol...
Tags for this Online Resume: Firmware, Agile, Management, Software Development, Linux, Program Management, Project Management, C/C++, Principle, Embedded, ASP.NET
Mechanical Engineer - 16 Years of Experience - Near 15220
Professional Summary An Engineering and Management Professional with extensive experience in Product Development and Engineering Consulting. Managerial Competencies * Service Delivery * Project management * Customer management * Onboarding new team * Performance management Technical Competencies Medical Devices/Life Sciences * Design remediation of medical devices * Remediation of Knee implant parts * Reverse engineering * ...
Tags for this Online Resume: Consulting, Medical Devices, Engineering Design, Engineering, Product Development, Documentation, Ansi (Am Natl Stds Inst), FDA
Production Supervisor - 6 Years of Experience - Near 27540
Summary of Qualifications: Results-oriented, high-energy, hands-on professional, with a successful record of accomplishments. Experience in production management, training, quality assurance, and customer service with focus on providing the recipient with the highest quality product. Major strengths include strong leadership, excellent communication skills, competent, attention to detail, dutiful respect for compliance in a...
Tags for this Online Resume: Leadership, Compliance, Distribution, Quality Assurance, SAP, Training, Training, Marketing Management, Warehouse, Advertising
Manager - 20 Years of Experience - Near 91203
Summary of Qualifications Versatile and innovative professional with extensive project and risk management experience within highly regulated environments. Includes over 10 years' experience within high energy, intense and stressful business environments. Analytical strategist skilled in successfully implementing processes that enhance organizational initiatives to ensure project are delivered on time, within budget and adh...
Tags for this Online Resume: Best Practices, Fabrication, Hardware/Systems, Infrastructure, Integrate, Leadership, Logistics, Management, Planning, Process Improvements
