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Online Resumes with "CFR 21"
QA/RA Manager / Senior Quality Engineer
I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.
Ideal Companies: New Start-ups
Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program
Senior Regulatory Writer (17 years experience)
I am seeking to end my present consulting status and return to an in-house position where continuity of projects is more realized. I have over 15 years experience writing regulatory medical documents that comprise CFR21 356h NDA/BLAs and eCTDs deliverables to the FDA/EU/Canadian regulatory authorities. I have written approximately 85 CSRs and can confidently say that ~40 of these were NCEs, early phase I/II and some pha...
Tags for this Online Resume: Regulatory Medical Writer Manager level
Biomedical Engineer
An innovative leader with a diverse set of business and engineering expertise to successfully manage design & development of marketable products. A team builder & great communicator with diversified biomechanical engineering product design, development and manufacturing experience including hands-on engineering research on cell –based & synthetic bone substitute materials, design and manufacturing of cutting edge class II &...
IT Professional - Versitle Expertise
IT professional with extensive experience in manufacturing across diverse industry sectors including medical devices and healthcare, non-profits and both mid-size and large companies including a Fortune 500 biotechnology company.
Ideal Companies: Large To Mid
Tags for this Online Resume: RPG ILE, DOS, DOS 5.0, DOS 6.2, Windows 3.0, Windows 3.1, Windows 95, Windows 98, Windows 2000, Windows XP, Windows 7, MS Offfice 2003, MS Offfice 2007, MS Offfice 2010, Lotus Notes, OutLook, Rockwell, Vision Systems, FDA, ISO, CFR 21 Part 11, SOX, Risk Managerment, Visual Basic, Avaya, MS Server, Rumba, AS 400, PEAK, RF, REMEDY, Peregrine, Project Management, KBO, KPI, SLA, SOA, Asset Manaagement, Manufacturing Support, Crisis Management, On Call, Remote Access, SMS, Travel, Relocation, Health Care, Distribution, Global, SDLC, Security, Flexibility, Customer Service, Automation, CLP, Diasaster Recovery, IBM, Contracts, Billing, Finance, Human Resources, Research Development, Testing, Validation, KeyTroller, Network, M-LAN, Anti Virus, Operating System, Wireless, Laptop, Desktop, Support, Acquisition, Outsource, Help Desk, Service desk
VP, CIO, Sr Director, SVP, EVP
I am an IT transformation leader driven to improve bottom line, develop high performance teams, security and compliance with agility along with advancing the company’s strategic objectives. I have extensive services experience in customer CRM multi-channel experience working Telecom, Financial, CPG, Medical Devices, MCO, Pharmaceuticals on DTC, OCT, grant processing, continuity programs, physician meetings, AE/PQC, Patient...
Tags for this Online Resume: Siebel CRM, MS/SQL, & Oracle, Avaya & Aspect VoIP , Cognos, BI, .Net, Web Portals, ISO/27002, PCI, HIPAA and CFR 21-par 11 regulatory compliance
Project Manager specializing in infrastructure technology
Project Manager specializing in infrastructure related projects and complex implementations. Comprehensive knowledge working within defined System Development Lifecycles
Ideal Companies: google
Tags for this Online Resume: Project Management, Operations Management, SDLC, Regulatory Compliance, CFR 21 Part 11, ITIL, CGMP
Business Technology Analyst, Carolina and Guayama Puerto Rico
Luis A. Jiménez Silva Tel. (787) - 653-6759 Home or Mobile 787-662-5229 E-Mail: luisjimenez0710@yahoo.com Skype ID: luis_jimenez_silva111 OBJECTIVE: I am seeking a challenging and opportunity position in Quality System Manage...
Tags for this Online Resume: Office Management, Green Belt, Project Management, LIMS Administrator, Process Supervisor, Quality System Validation
Senior Manufacturing Executive
I am a senior manager in a combination medical device manfuacturing company that aspires to contribute significant bottom line results at a senior level in a market leading consumer products or medical device manufacturing enterprise located in the south eastern US, preferably in the Miami or Atlanta Areas.
Tags for this Online Resume: Relocation, Supply Chain, Manufacturing , Medical Device, CFR21.820, ISO13485
Validation Documentation Writer, Validation Coordinator, Quality Assurance - 10 years Experience - Indianapolis
To work in a quality-driven environment, such as the biotechnical field, as a Validation Coordinator, Validation Writer, or Quality Assurance Manager.
Ideal Companies: Convance, Clarian, Roche Diagnostics
Tags for this Online Resume: GxP guidelines, Planning Documentation, Regulus, CFR21 Part 11, Testing Documentation, TrackWise, Good Documentation Practices, Microsoft Office
Management Specialist - Consultant
Results-oriented senior level managerial specialist/ consultant in the merchandising, plastics and medical device manufacturing sector with over 30 years of business experience in various corporate environments ready to help improve your corporate bottom line.
Tags for this Online Resume: quality assurance engineering, regulatory affairs, international sales, ISO 9000 CFR 21, quality systems management, technical specifications development
Technician - 20 Years of Experience - Near 53405
• Research and develment Senior Tech with 20+ yrs background with Medical device companies. Quality-focused, with broad knowledge and experience in administrating experimental studies and class B protocols in a research laboratory. • Expertise includes electro-mechanical troubleshooting and repairs, soldering circuit boards, replacing components, and providing technical support to field technicians, nurses and doctors. • S...
Tags for this Online Resume: Medical Device Senior Technician, Laboratory equipment IQ, OQ, PQ and test method validation, FDA and CAPA management, Testing, writing protocols, gauge R , Microsoft Excel, word, outlook, access, and power point, Certified in Blue Hill, , Product development, GLP, GMP, PPE, Engineering Change Request
Manager - 20 Years of Experience - Near 02343
Tags for this Online Resume: CFR 21 Part 11, Product Data Management , Documentation Management , Change Control , Process , SOP
