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Online Resumes with "fda "
Electrical Engineer - 20 Years of Experience - Near 66216
SUMMARY * More than 30 years of professional experience and progressive accomplishments in leading design, development, research, test, improving design and producing high reliable electrical & electronics circuits, components, systems, subsystems, customer service, and engineering practices with IEC 60601-1, FDA, ICE, UL, CE, FAA, FCC, Mil. Std. 461/DO-160 and DO-178/254 * Energetic self-starter, creative thinker, able to ...
Tags for this Online Resume: Firmware, Amplifier, C Programming Language, Integrate, Circuit Design, Test, Automatic Test Equipment, C++ Programming Language, C/C++ Programming Languages, Layout, electrical engineer
Toxicologist - 19 Years of Experience - Near 60134
SUMMARY I am a highly motivated individual that is driven to succeed, with proven strategic decision making ability and acute attention to detail, underscored by a career highlighted with numerous promotions and high level positions in successful industry and contract research laboratory (CRO) environments in an international setting. I have had great success at aligning cross-functional research and development teams to su...
Tags for this Online Resume: Analytical Chemistry, Applications, Attention to Detail, Compliance, Data Analysis, Data Management, Due Diligence, Good Clinical Practices, protocol, pharmaceutical, ich, GLP
Operations Manager - 16 Years of Experience - Greater Minneapolis
Working in the Medical Device Industry has created a drive to high detail and excellence in all I do. I am motivated and even excited by the challenge to solve new problems and improve the business through Lean Manufacturing Tools and people. My career objective is to benefit an organization using my skills as an Sr. Operations Manager or Director. Working across all departments, utilize current and future talent by empo...
Tags for this Online Resume: Kaizen, Training, Configure, Lean Manufacturing, Planning, Production Planning, Scheduling, Wang VS PACE, WIP, Single Piece Flow, Lean Six Sigma, Voice of Customer, Operations KPI, FDA, Regulatory Agencies, Leadership, Problem Solving/Root Cause, Operations Excellence, Accountability, Results Driven, Lead by example, Improved Efficiencies
Chemist - 15 Years of Experience - Near 92881
Experienced with trouble shooting issues in chromatography and other testing procedures resulting in effective and high quality test methods * Maintained daily, weekly, and quarterly checks of instrumentation such as stability chambers and HPLC systems as part of team responsibilities, reducing the need for a separate metrology group Scientist II (Laboratory Technical Services) 2011 Performed remediation activities for exis...
Tags for this Online Resume: Filing, Forth Programming Language, Quality Assurance, Regulatory Affairs, Test, High Performance Liquid Chromatography (HPLC), Instrumentation, Quality, Quality Control, Compliance, pharmaceutical, sop, change control, method validation, cleaning validation, hplc, fda, raw material, in-process testing, finished product, solid dose, research and development, method transfer, protocol, report
Quality Engineer - 20 Years of Experience - Near 92507
Personal Summary Extensive experience in Medical Device manufacturing (over 27 years) Worked with Pharmaceutical manufacturing industry (5+ years) Opened and reviewed complaints, performed investigative actions for submittal. Effectively work with cross-functional teams. Perform complaint investigations and reviews. Run root cause analysis, identification and implementation of CAPAs. Experienced with FDA auditors. Perform t...
Tags for this Online Resume: Quality Assurance, Documentation, Manufacturing, Pharmaceutical, Reviews, Compliance, ISO, ISO 9000, Packaging, ISO 9001, manufacturing, steel, production, quality
CEO of Quality/Regulatory Affairs- 19 Years of Experience - New York
SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...
Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL
Medical Equipment Repairer - 20 Years of Experience - Near 77014
Areas of Expertise * Technical Support * LIS Systems & Interfacing Principles * Strategic Planning/Analysis * On-site Service/Troubleshooting * Healthcare Diagnostics * Corrective Action & Preventive Measures * Analytical Instrumentation * FDA & Regulatory Requirements * Inventory Management * Customer Service
Tags for this Online Resume: Instrumentation, Hematology, Integrate, Services, Troubleshooting, Chemistry, Diagnostics, Automation, Inventory, Support
Quality Manager - 16 Years of Experience - Near 30038
SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...
Tags for this Online Resume: Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans
Network Engineer - 20 Years of Experience - Near 25428
Experience Summary Contract Officer Technical Representative at the Food and Drug Administration. Responsible for inventory control and licensing of the Cisco network equipment and the CA network management systems. Set up spreadsheets for inventory control, and calendar notifications as reminders when licensing information was due. As a sales consultant at Hagerstown Ford, I worked with customers from the beginning of the ...
Tags for this Online Resume: network, monitoring, Management, customer support, routing, switching
Clinical Regional Monitoring - 15 Years of Experience - Near 30067
SUMMARY OF EXPERIENCE Experience in clinical trial coordination, including initiating, administering and maintaining protocols with emphasis on FDA compliance. Therapeutic areas of experience include Cardiology (Hypertension), Infectious Disease (Prostatitis and UTI), Diabetes, Obesity, Respiratory, Nephritis, Irritable Bowel Syndrome, COPD, GERD and Pain Management (Osteo-Arthritis). Phases include II, III and IV.
Tags for this Online Resume: Clinical Research, Research, Documentation, Protocol, Billing, Chiropractic, Document Review, Filing, Health Insurance, Insurance, clinical, trial, protocol, pharmaceutical, phase, oncology, gcp
Plant Manager - 15 Years of Experience - Near 72000
Career Summary A challenging position and active involvement in a progressive organization offering the opportunity to fully utilize proven and developing skills. Summary of supportive Qualifications * 15 years of experience in Quality Assurance/Quality Control/Quality System * Excellent skills in Quality processes, Design Concepts (Risk Management) and Problem Solving. * Regulatory compliance (FDA QSR, CMDR, IS013485, MDD....
Tags for this Online Resume: Quality Assurance, Audit, Medical, Compliance, DFMEA, Documentation, manufacturing, ISO13485, Plant Management, Test, Quality Assurance Medical Device
Quality Assurance/Food Service Manager - 30 years experience - Butterball LLC. Burgar King
I am a experience manager int he food industry looking for a position in a stable company with growth potential for a seasoned manager with excellent people, development, marketing, sales, FDA, USDA and other governemental regulartory departments skills as well as HACCP, SSOP, SPS and GMP experience.
Tags for this Online Resume: Food Safety Management, HACCP Coordinator, General Manager, Fast Food Management, Quality Assurance Manager, Training Management
