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Were you looking for FDA-ISO job results?
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Online Resumes with "FDA ISO"
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Quality Assurance Specialist - 13 Years of Experience - Near 94506
SUMMARY Proficient in developing and applying Software Quality Assurance techniques and strategies to resolve problems in software and compliance with FDA regulation and ISO guidelines in Agile software development environments. Applied SQA principles and methodologies in Manual and Automated Testing with Real Time instruments. Tested instruments Firmware and Drivers. Created, modified and executed test plan and test cases....
Tags for this Online Resume: Real Time Instruments, Test Case Development, FDA, ISO standards, Visual Studio Test Management, Manual and Automated Test, Agile software development, TFS, TestTrack, C#, Python, Troubleshooting, Medical Devices Firmware, Drivers, 21CFR Part 11, Life Science, Data Analysis
Quality Manager - 15 Years of Experience - Near 46143
SUMMARY A results-oriented achiever with a rich background of diverse responsibilities in the medical diagnostic and pharmaceutical industries. Exceptional relationship building skills. Track record of a self-starter, constantly looking to identify and implement cost reductions, product and process improvements. A strong communicative, organized, detail oriented, and project planning/executing leader. Skilled in managing no...
Tags for this Online Resume: Management, Document Management, Quality Assurance, Test, ISO, Project Management, Project Manager, SAP, Documentation, Orthopedics
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Mechanical Engineer - 15 Years of Experience
Career Summary 10+ years' experience in Project Management, R&D, Medical Devices, Film, Paper & Plastic Converting, RFID, Semiconductor, Automotive & Textile Industries Areas of Expertise Working under pharmaceutical OSHA / FDA / ISO regulated requirements
Tags for this Online Resume: Documentation, ISO, Manufacturing, OSHA, Pharmaceutical, RFID, Security, Medical, Medical Devices, TQM (Total Quality Management)
Technical Manager in Manufacturing- 11 Years of Experience - Near Salt Lake City, UT
Seeking Operations or Sr. Engineering Manager position. Methodical, innovative, and results-driven leader with hands-on experience in regulated and non-regulated industries, focusing on strategic planning and operational excellence. Effective at developing and implementing strategies to attain set-forth business key performance indicators (KPIs), maximize growth opportunities, and streamline processes and company operations...
Tags for this Online Resume: Manufacturing, Reliability, Process Improvement, Instrumentation, Matlab, Troubleshooting, Complaints, Data Analysis, Diagnostic Tools, Ethernet
Biological Technician - 3 Years of Experience - Near 94303
Summary: Experienced commissioning engineer with over 12 years of practical experience in biotech. Proficient with most equipment related to cell culture fermentation, and oral solid dose pharmaceutical manufacturing facilities. Very strong in GMP documentation FDA, ISO 9000, cGMP, CFR title 21 and DEA regulatory compliance. Familiar with LIMS, BMS, Trackwise, Faciliworks, Word, and Excel.
Tags for this Online Resume: Documentation, Automation, Honeywell, Schematics, Pharmaceutical, Science, BMS, Compliance, Good Manufacturing Practices, ISO, Validation
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
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Chief Executive Officer - 20 Years of Experience - Near 33410
Career Highlights I have Intellectual Property in collaboration portals to enhance cross functional communication and organizational efficiency which has previously deployed across Health Care Providers (HCA), Healthcare Consultants (Studor Group), and Payers (BCBSVT). I successfully sold my software development and consultancy business and looking for new challenges. Entrepreneurial Leader with 3 Successful launches in the...
Tags for this Online Resume: Semiconductor Industry, Semiconductors, Start up, MicroElectronics, Fab, Intel, IBM, Management, Manufacturing, Acquisitions, P&L, IPO, VC Private Equity, Global Network
Electrical Engineer - 11 Years of Experience - Near 10930
Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...
Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery
Materials Manager
SUMMARY Global R&D Innovation Leader, 20+ years of experience in CPG food and biopharma packaging, overseeing polymer materials and packaging equipment platforms. Team leader in the introduction and commercialization of barrier coextruded structures and bioplastics in food and medical packaging. Change agent in productivity improvement, and cost reduction initiatives. Overseas assignment as Site Manager at Kraft Venezuela's...
Tags for this Online Resume: Budgeting, Inventory, Purchasing, Quality, Sourcing, ISO, Applications, Marketing Management, Packaging, Transportation, healthcare, pt
