CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "13485"

Quality Manager - 20 Years of Experience - Near 37129

SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...

Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering

Mechanical Engineer - 20 Years of Experience - Near 44133

ACCOMPLISHMENTS Manufacturing Engineer * Created work and test instructions, Manufacturing process plans (MMP) for Boeing components and other aerospace and defense programs. * Managed the construction, fabrication, and delivery as lead manufacturing engineer for the SD02 project for structure test for panels used in the ARES 1 Rocket at Marshall Space Flight Center * Led manufacturing engineering efforts for the Ascent Abo...

Tags for this Online Resume: Management, Quality Assurance, Complaints, Reviews, Manufacturing, Engineering, 5S, Autocad, Autodesk AutoCAD, Document Review

Quality Manager - 20 Years Experience - Tijuana BC Mexico

SUMMARY Professional with over 19+ years of experience in large world-class multinational companies, medical, automotive and metalmechanic industries, Electronics EMS. An accomplished Quality Professional with solid and extensive background in Quality. Dynamic leadership skills and complex problem-solving abilities. Experienced communicator with practical execution of Six-Sigma, FMEA, APQP, PPAP, SPC, DOE, IQ, PQ, OQ, FAIR ...

Tags for this Online Resume: Automotive, Customer Service, Manufacturing, Quality, Quality Assurance, Quality Control, Test, Internal audit, PPAP, Audit, ISO 9001, ISO/TS 16949, ISO13485, AS9100, IQ,PQ,OQ

Agile Software Director / Senior Manager - 20 Years of Experience - Near 05403

10+ years of experience as a software engineering manager Graduate of 10 GE leadership courses. Experience with database and data access technologies, application development and security frameworks Knowledge of existing Progress technologies Expert understanding of software development processes and lifecycle management including SAFe. Solid technical experience in management of both emerging products and established prod...

Tags for this Online Resume: EDI, Engineering, Quality, Compliance, Integrate, pmp agile .net mssql 13485, HL7, pmp, agile, Scrum, Software, Medical Device Global Compliance

Quality Engineer - 17 Years of Experience - Near 76210

Established Quality Systems (256) 593-1260 Sampling Plans within the Custom Fabrication & Welding areas that corresponds to TS 16949 and QS 9001 Quality Systems. P: 481 - 1120 office.) (248) 447-1500

Tags for this Online Resume: Engineering, Purchasing, Corrective Actions, Root Cause Analysis, Management, Quality, Quality Assurance, Transmissions, Documentation, ISO, ISO 9000, ISO 13485, Fishbone, 5 Why, Medical Device, Automotive, OIl & Gas, Industrial-Locomotive Production, Process Engineering, Tool Designer, Manufacturing, Wire Harnesses, Consumer Goods, Medical Devive, Six Sigma/Kaizen, Continuous Improvement

Clinical Quality Assurance - 15 Years of Experience - Near 73099

SUMMARY Professional with increasingly responsible experience in quality assurance, regulatory affairs and clinical operations. Proven success in leading projects and people within the pharmaceutical and Life Sciences industry and within the military. In addition to strong and engaging leadership skills, strengths include a thorough knowledge of pharmaceutical industry guidelines and regulations, including GMP, GCP and ISO ...

Tags for this Online Resume: Management, Clinical Operations, Integrate, Manufacturing, Complaints, Genotyping, Quality, Quality Assurance, Audit, Compliance, training, audit

Microbiologist - 20 Years of Experience - Near 80503

Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...

Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing

Mechanical Engineer - 19 Years of Experience - Near 45039

SUMMARY * Strong expertise in System Engineering, Mechanical design, FEA & Vibration testing * 19 years of industry experience in product development and project management * Medical device design experience familiar with ISO13485 and FDA 21 CFR 820 Standards * Extensive knowledge of electro-mechanical, fluid mechanics and heat transfer * High-level in multitasking using communication, presentation, and management skills * ...

Tags for this Online Resume: Management, Project Management, System design, Systems Engineer, HVAC, Engineering, MEMS, Research, Instrumentation, Legacy

COO - 20 Years of Experience - Near 95112

HIGHLIGHTS OF QUALIFICATIONS High performance, results driven manager, with more than 20 years of front line operations of both in-house and contract manufacturing experience. Extensive international/multi-cultural skills demonstrating leadership and expertise, including the differing and unique needs of commercial, OEM, and government customers. Responsible for transitioning operations to world class standards, while actin...

Tags for this Online Resume: P&L, Inventory, Inventory management, Operations, ISO 9001, Business Management, Quality Control, Program Management, Problem Solving Skills, ABS, General Manager, Manufacturing, CNC Machining, Assembly, Sales, Customer Relations, Medical Devices, ISO 13485, Production, Vice President, COO

Quality Assurance Manager- 17 Years of Experience - Near 91790

Highly motivated candidate, fluent in Spanish, with over 17 years of experience working in the medical device industry from feasibility & design to manufacturing and distribution. Interested in broadening my career management opportunities with another medical device manufacturer. Strengths are in leading people, project management, setting up various departments within the organization and helping to establish quality syst...

Tags for this Online Resume: Quality, Medical, Medical Devices, ISO, Management, Complaints, ISO 9001, ISO 13485, 21 CFR

Quality Assurance Director - 17 Years of Experience - Near 03062

SUMMARY A resourceful, determined and results driven global quality assurance & regulatory affairs leader with 17 years of experience in R&D, internal & contract manufacturing operation (CMO), supporting domestic & international markets.

Tags for this Online Resume: Product Development, Engineering, Management, Manufacturing, Reviews, Risk Management, Kaizen, Regulatory Affairs, Automation, Compliance, compliance, ASQ, ISO 13485, Design Control, CAPA, Quality Management System, 510k

Quality Manager - 12 Years of Experience - Near 36109

Over Twelve years' experience in the field of Quality Assurance and Operations in the (Automotive Environment and Medical industry) * On job utilization of SPC Engineering and techniques Black Belt Six-Sigma Deployment Process Capability studies Poka-Yoke (Error Proofing) APQP PPAP (ISIR) Gage R&R GD&T 8D and Control Plan Methodology Involvement in continuous process improvement (Kaizan 5S/6S) and Problem Solving activities...

Tags for this Online Resume: Automotive, ISO, Management, Corrective Actions, Heat Exchangers, Integrate, Manufacturing, Packaging, Quality, Quality Assurance, manufacturing, "project management", production