CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21CFR"

Director of Quality - 20 Years of Experience - Near 75063

Accomplishments included significant reductions in customer complaints, up to 50% over 60% reduction of rework increase in percentage Right-First-Time, to reach RFT >99% recalls prevention reputable audit certifications plant readiness for audits. * Promoted from Quality Assurance Manager to Plant Manager after a few months in the company due to the immediate impact on the organization's transformation from an environment o...

Tags for this Online Resume: Compliance, Quality, Quality Assurance, Quality Control, Test, Audit, Complaints, Consulting, Defense, Internal Auditor, manufacturing, Director and consultant of food safety and quality

Quality Assurance Specialist - 20 Years of Experience

Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....

Tags for this Online Resume: Data Analysis, Medical, Complaints, Quality, Risk Analysis

Industrial Engineer - 15 Years of Experience - Near 06422

SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...

Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,

Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

Quality Engineer - 13 Years of Experience - Near 92630

I enjoy working with start-up or multi national/ global medical device companies. Apply my experience in mechanical engineering to design & development, remediation projects for class II medical devices.

Tags for this Online Resume: Product Development, Manufacturing, Medical Devices, Product Design, Training, Documentation, Packaging, Test, "project management", production, mechanical engineer, Project Engineer, USFDA 21 CFR (QSR), ISO 13485 (QSR), ISO 14971 (Risk Mngt), MDD/93/42/EEC, QA Engineering, Contract Eng. Start-up & Multi National/Global

Quality Assurance Specialist - 7 Years of Experience - Near 75093

Professional SUMMARY * Over all 7 years of experience in the IT industry in Quality Assurance using Web based and Client/Server applications. * Knowledge of Healthcare, Pharma, Security and Biometric projects. * Key expertise includes testing Extensive experience in Manual and Automated testing using Selenium and defect tracking tools like HP Quality Center (ALM/QC), Bugzilla, JIRA and Bug Zero. * Conversant with all phases...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server

Not Listed - 17 Years of Experience - Near 53562

Areas of Expertise * Quality Engineer * Non-Conformance * Auditing * Product Surveillance * Training & Staff Development * Medical Device & Pharma * Complaint Review * Policy & Procedures * FDA/MDR Reporting * Subject Matter Expert * Complaint Investigation * 21CFR Part 210 and 211 * 21CFR Part 820 and 803 * ISO 9001, 13485 & 14001 * Laboratory Testing * Calibration and Validation * Federal Compliance * International Compli...

Tags for this Online Resume: Quality, Quality Assurance, Systems Operations, Documentation, Instrument Calibration, Notebook Computer, Project Coordinator, Process Improvement, Typing, Inventory, human resources

Production Manager - 20 Years of Experience - Near 01702

Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...

Tags for this Online Resume: Lean Manufacturing, Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical, Purchasing, Quality Assurance, manufacturing

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

Clinical Quality Assurance - 13 Years of Experience - Near 92057

QUALIFICATIONS: Over 13 years of experience in the Pharmaceutical and Medical Device Industry. I have a proven desire to enhance team effort and first time quality concepts, Strong creative research skills, Strong detailed and task oriented skills. Work environment regulated by 21 CFR 820 and ISO 13485:2003 & 9001. Specialized in Quality Assurance, Regulatory Compliance, GMP, Document Control, QSR training, Excel, Power Poi...

Tags for this Online Resume: Compliance, Accounts Receivable, Customer Service, Inventory, ANSI, Ansi (Am Natl Stds Inst), Training, Audit, Document Control, ISO

Director of Quality

Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12 of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, project-management and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...

Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management

Statistical Programmer - 5 years Experience - US

Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...

Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test