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Online Resumes with "MDD "
Design Assurance, Regulatory Compliance - medical device
Tags for this Online Resume: ISO 13485, ISO 14971, ISO 9001, Engineering , MDD Harmonized Standards, CE Marking
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume: Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
Biostatatician
SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...
Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical
Programmer Analyst - 20 Years of Experience - Near 30083
AREAS OF EXPERTISE * Data processing/Data tabulation * Confirmit (Survey Programming) * Qualtrics (Programming) * Dimensions (Tabulations) * SPSS/SQL * Quantum (Tabulations) * Extensive experience in data preparation and preparing for meaningful analysis * Highly qualified in data consistency * Strong knowledge of Word/ Excel * Excellent communication skills * Ability to manage multiple projects at once * Extremely creative...
Tags for this Online Resume: Documentation, Surveys, Test, Training, Troubleshooting, Web, Adobe Dimensions, Coding, Data Management, Management
Not Listed - 20 Years of Experience - Near 94704
Professional Profile Pg 3 of 3 Hanan Altschuler, Machine Builder/Technologist - Process / Mechatronics Engineer P. O. Box 265, Berkeley, CA 94701 Forensics / Productivity and Quality / Validation E-mail: hanan@lmi.net Other Specialized Experience: * Use of multi-disciplinary approach to design products incorporating optical, mechanical, electrical, chemical, biological, and other technologies in a single product with compli...
Tags for this Online Resume: ANSI, quality, Automation, Automotive, CNC, Compliance, DFS, Documentation, Engineering, Failure Analysis, R&D, industrial design
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
Quality Manager - 17 Years of Experience - Near 60051
SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...
Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management
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
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 Manager
SUMMARY OF QUALIFICATIONS 21 years hands on experience in the Medical Device industry dealing with ISO, MDD & FDA compliance. 11 years regulatory affairs experience.
Tags for this Online Resume: Assessments, Inventory, Inventory Control, ISO, ISO 9001, Management, Product Design, Quality, Quality Assurance, Quality Management
Director of Quality - 20 Years of Experience - Near 91325
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...
Tags for this Online Resume: Test, Engineering, Reliability, Management, Manufacturing
Health Technologist - 0 Years of Experience - Near 11746
SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...
Tags for this Online Resume: Management, Medical, Operating Room, Policies and Procedures, Project Management, Rf, Software, Software Development, Surgical, Test
