CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "PMA"

Production Supervisor - 15 Years of Experience - Near 60110

SUMMARY Proven success supervising and coordinating the activities of direct labor hourly employees, and leading high performance team of forming and fabricating equipment to produce sheet metal products. Thrives at learning and excelling in difficult or unfamiliar environments. Strong leader with proven ability for management, and implementation of new strategies while handling multiple projects. Adept at interpersonal ski...

Tags for this Online Resume: Manufacturing, Kanban, Kronos, Kronos (Labor Mgmt Sys), Lean Manufacturing, Management, Microsoft, Microsoft Excel, Microsoft Office, Microsoft PowerPoint

Chemist - 13 Years of Experience - Near 07728

To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...

Tags for this Online Resume: Chemistry, Research, Sar

Department Manager - 20 Years of Experience - Near 46032

SUMMARY Strategic Leader with expertise in creating high performing teams in Engineering, Maintenance, Reliability, Operations, and Facilities. Proven successes in knowledge transfer, process mapping, configuration management and improving quality in fast-paced environments. Technically driven with engineering background and strong track record in setting and meeting metrics and accountability in the avionics, cryogenics, D...

Tags for this Online Resume: Project Management, Project Manager, Purchasing, Quality, Quality Assurance, Distribution, HVAC, Insulin, Manufacturing, Reliability, Maintenance, Smelting, Utilities, Medical Devices, Planning and Scheduling, Change Management, DoD, Pharma, Fermentation, High Purity Water, Maintenance Management, GMP, Lean Manufacturing, Six Sigma Green Belt, Environmental, Health and Safety, Knowledge Transfer

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

Quality Assurance Specialist - 7 Years of Experience - Near 55446

SUMMARY: * Around 7 years of experience in Software Testing in Web based Application, Insurance, Healthcare and Banking Applications. * Proficiency in defining, formatting and executing Test Cases based on Business Requirements Ensuring the Traceability for the requirements throughout the testing process. * Good knowledge with Medial Devices (such as ISO13485 standards, IEC60601, FDA processes such as PMA, 510k, Validation ...

Tags for this Online Resume: Java Programming Language, Test, Test Cases, Microsoft Windows, Structured Query Language, Management, Regression Testing, Test Plans, Acceptance Testing, Agile, sql

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

Project Manager - 20 Years of Experience - Near 91302

SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems...

Tags for this Online Resume: Database, Database Design, Integrate, Business Requirements, Javascript, BASIC Programming Language, FACETS, Hospital Information Systems, HyperText Markup Language, Legacy, Project Management, Agile, Scrum Master

Regulatory Affairs Associate, San Francisco, Santa Clara area. 510K, PMA submissions, International registrations, FDA and TUV audits audits

Tags for this Online Resume: Regulatory affairs, Regulatory compliance, Drug Enforcement Administration DEA, Associate, Coordinator, Administrative Addistant

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

Executive Assistant - 14 Years of Experience - Near 91354

Summary: I have excellent organizational interpersonal skills, verbal and written skills. I exhibit a dedicated conscientious attitude toward overall activities. I demonstrate high levels or multifunctional capabilities and I am an ambitious team player. I work well with minimum supervision and am self-directed. I am inspired to my education in business management. Qualifications: * More than 20 years experience in C-level ...

Tags for this Online Resume: Billing, Management, Travel, Medical, Switchboard, Therapy, Administrative Assistant, Blue Prints, Blueprints, Clinical Research, administrative assistant, clerical

Quality Assurance Director - 18 Years of Experience - Near 55379

Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...

Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management