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Online Resumes with "fda "



Featured Profile

Biomedical Equipment Technician - 30 Years of Experience - Portland, OR.

top-performing healthcare professional, with strong expertise in performance of FDA 510K certified medical equipment management, repair and maintenance. Certified in clinical hemodialysis, water purification and hemodialysis technology. Highly accomplished in technical education; staff development, CQI principles and quality assurance. Ensure compliance with all federal, state and company regulations, policies and procedur...

Ideal Companies: Fresenius Medical Care; Kaiser Permanente; Providence Health & Services; Legacy Health System; Intel; State of Oregon; City of Portland, OR; Multnomah County, OR; Clackamas County, OR;

Tags for this Online Resume: Healthcare, Biomedical, Water Treatment, Hemodialysis, Quality Assurance, Repair, Maintenance, Customer Service, Technical Writing, Technical Education, Staff Development, Regulatory Compliancce, Inventory, MS Office, Water Microbiology, Patient Care, OSHA Regulations

Clinical Research - 5 Years of Experience - Near 08901

I hope to reenter the clinical research setting utilizing my law degree focusing on trial management, compliance, and regulatory work.

Tags for this Online Resume: law degree, research coordinator, FDA, GCP, clinical trials, CRA

Featured Profile

Lawyer - 13 Years of Experience - Near NYC

Attorney with unique litigation, corporate finance and regulatory experience. Recognized as an extensively experienced senior litigator, transactional attorney and regulatory specialist with over twelve years of proven success in bench and jury trials, and at the appellate level, winning in court as well as at the negotiating table. After building a successful small law practice I am looking to transition to back to an in...

Tags for this Online Resume: Securities Law , Regulatory Compliance , FINRA and NYSE Rules, New Jersey, Anti-Money Laundering and Bank Secrecy , U.S. FDA laws, Federal Food, Drug, and Cosmetic Act

Out going team player!

Ideal Companies: MetLife, Hearst, Donald Trump, Mars,

ERP - 8 Years of Experience - Near 30180

Over 8 years of combined experience in manufacturing SAP execution and discrete biological fluid manufacturing. I work as SAP manufacturing specialist for Ortho Clinical Diagnostics Raritan NJ. I am SME for manufacturing execution for SAP. I have worked on various SAP projects including BOM updates and SAP tester during SAP implementation. During the SAP implementation project I worked on various stages of the project from ...

Tags for this Online Resume: SAP MM, SAP PP, SAP QM, Six sigma green belt, FDA , Biologicals, cGMP, Manufacturing, Planning, SAP, MRP, 5S, Accounting, Audit, Business Intelligence

Production Manager - 15 Years of Experience

My name is Edna Torres, honest, respectful, responsible and committed. Excellent experience as Manager in different operations areas, as sterilization, packaging, inspection, compounding, sterile processes as filling and clean rooms sanitation. Contract manufacturing partnership, different types of medical devices and others.I'm confident that I can met your requirements as an experienced professional. Thanks for the opport...

Tags for this Online Resume: sterilization, sterile filling and compounding, biological products, CAPA, continous improvement, FDA audit, Packaging, automatic and manual Inspection

Distribution manager - 20 Years of Experience - Near 34481

LONG TERM MANAGER WITH EXTENSIVE EXPERIENCE IN cONSTRUCTION,PRODUCTION, PACKAGING, SHIPPING AND RECEIVING, LOGISTICS AND TRANSPORTATION,SAFETY AND FOOD SAFETY, USDA AND FDA COMPLIENCE.

Tags for this Online Resume: Florida, Dedicated, Honest, Driven, Company, Integrity, Professional, Results

Quality Manager - 20 Years of Experience - Near 60096

Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...

Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor

Clinical Research - 14 Years of Experience

Nursing professional with management experience in conducting phase Ib – IV pharmaceutical clinical trials in Cardiovascular, Endocrine, Respiratory, GI, and Immunology diseases. Broad base knowledge of FDA regulations and Good Clinical Practices for study start-up, execution, and completion using applicable SOPs and site policies and procedures

Tags for this Online Resume: Research Nurse Coordinator, Drug Safety Specialist

Medical Technology-11 years, Quality Assurance- 15 years, Quality Engineer 6 years, Product specialist - 4years,

Strategic Senior Product Specialist and Senior Quality Assurance Engineer with 18 ears experience driving quality initiatives for regulated Class III medical devices. Extensive knowledge of GMPs and FDA regulations. Experience includes Diagnostics and Hospital Laboratories. Unique combination of expertise in clinical developmental, implementation of new products, logistics, Root Cause and Corrective Action, cost reduction i...

Tags for this Online Resume: Logistics, manufacturing, Supplier Quality Engineer, Operations, Customer service, QA/QC testing

General Counsel / Nurse Attorney - 20 Years of Experience - Near 67039

Use my experience as a nurse attorney [who used to litigate defective pharmaceutical and medical device cases & doing risk management & FDA regulatory reviews] to consult with various companies, healthcare providers to educate them about problem products and reduce their risks.

Tags for this Online Resume: telecommuter, nurse/attorney, auditor/risk manager, human resources, lawyer/attorney, Registered Nurse, board member, executive

Featured Profile

Senior Process Validation Lead

Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.