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Online Resumes with "cfr"



Mechanical Engineer - Near 77072

SUMMARY: * 25 years of experience in Mechanical & Piping Field/Construction/Design Engineering, Project Engineering, Oil & Gas, Process, Power Utility Systems/Maintenance Engineering * Managed various Mechanical Utility Systems, Supervision and Design/Construction in Mechanical components & piping systems for Various DOE/Commercial Projects. * Responsibilities have included working closely with clients, management, and in a...

Tags for this Online Resume: Test, Test Plans, NCR, Test Plan, Quality, Valves, Management, Project Management, Utilities, Consulting

Quality Manager - 20 Years of Experience - Near 28269

Summary of Qualifications and Accomplishments * Demonstrated excellent Quality Management/ Engineering work experience, providing technical support to customers, suppliers, cross-functional team members, and manufacturing on new and existing products. * Knowledgeable and experienced with SMT, PTH, Hybrid, Chip on Board, Power Supply, and Fiber Optic technologies to assemble, test, and box build printed circuit boards in sup...

Tags for this Online Resume: ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering, ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering

Department Manager - 5 Years of Experience - Near 92591

SUMMARY OF QUALIFICATIONS * Possesses extensive technical writing skill created technical manuals, Standard Operating Procedures, maintenance procedures, and training documentation * Investigate and resolve system integration problem areas interfacing with engineering, operations, and maintenance personnel to document the technical solution * Reviewed and revised technical documents for quality (content, accuracy, and forma...

Tags for this Online Resume: Electronics, Management, Material Management, Documentation, Security, HVAC, Hydraulics, Manufacturing, Utilities, Engineering, CMMS, Reliability

Quality Professional

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Microbiologist - 20 Years of Experience - Near 07753

Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...

Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap

Engineering Manager - 20 Years of Experience - Near 94552

Tags for this Online Resume: Associate in Commercial Underwriting, Technical Writing, Integrate, Engineering, Instrumentation, Programming, Support, Weapons, Assessments, Automation, pharmaceuticals, validation, engineering, CSV, 21 cfr part 11, risk, protocols, GMP, facilities, medical device, FDA, ICH, EU, GAMP, change control, validation master plan, facilities master plan, aseptic processing, packaging, packaging line, WFI, clean steam, PW, SIP, CIP, process validation, critical process paramters, capital project, project management, electronic record, strategy, planning, leadership, solid dose, standards

Sr. Manufacturing Tech with experience in Quality Assurance

SUMMARY * Strong scientific skillset acquired at academic and industry level. * 3+ years' work experience in the US Biotech industry with vast knowledge of GMP, GLP and ISO standards and regulations. * Detail oriented, diligent and ability to work in teams on multiple projects. Familiarity with 21 CFR pertaining to GMP in bioprocessing, GLP, FDA regulations and bioethics.

Tags for this Online Resume: Good Manufacturing Practices, ISO, QA, GMP, cgMP, gcp, biotech, quality assurance, GLP

Production Manager - 20 Years of Experience - Near 00727

SUMMARY OF QUALIFICATIONS * Fully bilingual (English/Spanish) * 25 years of proven experience in the Manufacturing and Industrial Engineering field. * 24 years of Supervisory experience including exempt and hourly personnel in demanding manufacturing environments up to 125 employees. * Exposure to FDA, EHS, ISO certification and internal audits * Knowledgeable in the application and interpretation of labor laws, both federa...

Tags for this Online Resume: Compliance, Facilitator, Manufacturing, Process Improvement, Bilingual, English Language, Engineering, Industrial Engineering, manager

Director of Quality - 17 Years of Experience - Near 77386

Career Summary Thirty-nine (39) years of experience in the development, management, training, implementation and evaluation of Quality Management Systems at Company and Project levels. This experience has been gained within a variety of industries (e.g.: Nuclear, Oil and Gas (Subsea-sea, Facilities, Pipeline, Pipe-lay, FPSO, Platforms, etc.), manufacturing, etc.). The majority of this experience has been at a management lev...

Tags for this Online Resume: ISO, Management, Project Management, ISO 9001, Quality, Quality Assurance, Quality Management, Test, Configuration Management, Configure, manufacturing, production, "project management"

Scientist - 20 Years of Experience - Near 92620

SUMMARY Medical device management professional (MS, MBA) with leadership experience in Stage Gate Product Development Process (PDP), Class I, II and III devices, Systems Engineering, Design Control, Quality Systems Requirements, clinically relevant strategic roadmap creation, capital equipment, IP portfolio management, market-driven technology development, product development, business development, project management, drug/...

Tags for this Online Resume: Business Development, PET, Therapy, Diversity, ISO, Management, Orthopedics, Product Development, Trauma, Cardiovascular, Medical Device leadership

Plant Manager - 20 Years of Experience - Near 73044

Qualifications Profile * Process Improvement: Developed tracking metrics for production and employee assessment to drive production and increase employee reliability. Excel at refining processes to increase productivity and profitability. * Business Development: Proven leader in identifying and resolving issues before they become larger problems. Leveraging work stream and work station analysis and optimization to increase ...

Tags for this Online Resume: Management, Compliance, Layout, OSHA, Packaging, Reliability, CNC, Fabrication, Hydraulics, Lathes, 5S-Six Sigma, SQF - CFR 111, Warehouse Operations, Inventory

Manager - 10 Years of Experience - Near 91387

QUALIFICATIONS * Customer-focused / diplomatic / tactful / positive / upbeat * Superior Manager / coach / trainer / mentor / solution-oriented / highly organized * Persuasive oral / written communicator / high level of motivation / aptitude * Interact well at all levels internally and externally / excellent stability * Adept Team Leader or function well as an individual contributor * Resourceful problem solver / outstanding...

Tags for this Online Resume: Compliance, Distribution, Test, Collection, Team Lead, Customer Service, Flooring, Inventory, Inventory Control, Retail, assistant manager, management