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Online Resumes with "ISO 14971"
Principal Engineer
ACCOMPLISHMENTS * Project management of Medical Device right from conceptualisation to manufacture in an ISO/FDA regulated environment. Used suitable stage gates and milestone list to inform key stakeholders about progress of the project. * Planned the project budget, schedule and used change control procedures for controlling changes and preventing scope creep. Negotiated with functional managers for resource allocation an...
Tags for this Online Resume: Medical, Medical Devices, Engineering, Instrumentation, ISO, Management, Cancer, Documentation, Manufacturing, NPI
Medical Transcriptionist
Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...
Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control
Principal Quality Engineer, CAPA, New Product Development
Searching a position as senior/principal quality, manufacturing, R&D engineer focused in mitigation, remediation, redesign and process change for cost savings and product quality enhancement, CAPA initiation and execution, and new product development.
Ideal Companies: medical or Aerospace industries
Tags for this Online Resume: Manufacturing, Medical Devices, Product Development, Research and Development, R&D, IQ/OQ/PQ, Pfmea, Dfmea, Certified Quality Auditor, Six Sigma/ Lean Sigma Green Belt, Quality Foundation Deployment Green Belt, MiniTab, Managing Cross Functional Teams, Solid Works Design, Conceptual Design, New Product Development, Risk Analysis, Negotiations, Customer Relations, Value Engineering, Decrease Field Failure, Increase Customer Satisfaction, Report writing, Authoring and enhancing Standard Operating Procedure, ISO 13485, ISO 14971, ISO 60601-1, Authoring Quality Manual, Design Validation, Verification, Valves, Switches, Linkages and mechanism design and development, Complaint Handling
Engineering Manager - 31 Years of Experience - Near 85224
Engineering project manager with 25 years' experience designing and manufacturing medical devices and 6 years' experience in business ownership and sales. Driver of all aspects of projects from gathering customer requirements to production release. Specialist with Class II and III combination products. FDA-recognized expert with Design Controls. Highly skilled people and situation manager. Leader at coordinating all depart...
Ideal Companies: Medical Device Companies, Employees 0f 100-250
Tags for this Online Resume: Microsoft Windows, Design Controls Expert, Engineering Project Manager, CAPA Investigator, Technical Sales, ISO 13485, ISO 14971, Internal and Vendor Auditor, FMEA, 510(k), Patents
Experienced Quality Assurance Engineer
Experienced Quality Assurance Engineer With demonstrated history of working in the consumer electronics industry, Skilled with HP,JIRA, Quick Test Professional(QTP), RMA Agile Methodologies, And detail knowledge about FDA procedures in Quality Engineering.
Tags for this Online Resume: MySQL, Java, Jira, ISO 13485, FDA, Systems Testing, C#
Clinical Regulatory Affairs - 20 Years of Experience - Near 80023
SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...
Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp
