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Online Resumes with "ISO 13485 FDA"
Aircraft Rigging Assembler
A fast track, highly motivated, team oriented technical professional with a strong background in implementing product transfer, new product introduction, new laboratory set up, and validation activities related to GMP PART 820, ISO13485 and FDA requirements. More than ten years new product quality engineering experience in device, pharmaceutical, R&D/Manufacturing environments, and four (4) years R&D experience with semicon...
IT Director, 20 Mapping IT solutions across engineering, Quality, Manufacturing and sales supporting corporate business directives
Advancement to VP IT or CIO level position, past broud company experience provides solid foundation
Tags for this Online Resume: erp, crm, windchill, plm, sap, life sciences, iso, iso 13485, fda, fda 820, quality, six sigma
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases. *Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances *Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files. *Review design control documents including protocols and reports associated with design inputs and outputs. *Interested in international m...
Tags for this Online Resume: regulatory, quality, medical device, international regulatory, FDA, 510k
Manager - 10 Years of Experience - Near 80022
Dedicated IT solutions architect knowledgeable in medical imaging departmental workflow, as well as imaging informatics, CT, and MR clinical application integration. Reliable project leader with dynamic problem solving abilities expertly applied to implementing systems and troubleshooting complex Tier 3 issues. Combine professional demeanor with collaborative and diplomatic communication strengths to liaise across multiple ...
Tags for this Online Resume: Customer Service, Help Desk, Windows, VMWare, Citrix, Training, Solutions, MSOffice
Biomedical Engineer - 2 Years of Experience - Dallas
SUMMARY: Biomedical Engineering graduate student with a specialization on Medical Imaging and Instrumentation. Hands on experience in operating complex medical equipment and expertise in image processing. IISE Certified Six Sigma Green Belt. Knowledge of ISO 14971, ISO 13485 and FDA regulations. Independent researcher, Dedicated, Self-Driven, Self-Motivated, Result Oriented, Team Player, Detail Oriented, and a Quick Learner.
Tags for this Online Resume: Data Analysis, Matlab, Biomedical Industry, C Programming Language, C++ Programming Language, Connectivity, Engineering, Green Belt, Image Processing, Imaging
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
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
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
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
Biochemist - 18 Years of Experience - Near 44202
Professional Summary I have over ten years of experience in the Biotech industry in both Research and Development and Quality Control). Accomplishments/Skills Technical experiences skills including: * Protein purification using anion exchange, affinity, HIC and SEC as well as HPLC. * Operation of an Agilent and Water's HPLC * Operation of the GE AKTA and Bio-Rad NGC FPLC systems * Cloning and expressing proteins in E. coli....
Tags for this Online Resume: Process Improvement, Troubleshooting, High Performance Liquid Chromatography (HPLC), Quality Control, Research, Manufacturing, Protein Purification, Protein Analysis, ELISA Assay, Western Blot analysis, qPCR/PCR, Cloning, cGMP
Life Scientist
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices
Life Scientist
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices
