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Online Resumes with "ISO Standards"



Technical Writer, Philadelphia metro, NYC, Connecticut, New Jersey

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Validation, Technical Writer, Microsoft Excell, Change Control, Microsoft Office, Microsoft Visio Professional, Microsoft Word, GMP

General - 7 Years of Experience

KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/E...

Tags for this Online Resume: Complaints, Good Clinical Practices, Medical, Pharmaceutical, Support, Technical Support, Clinical Research, Project Management, Project Manager, Research

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

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

Featured Profile

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

Business Analyst - 15 Years of Experience - Near 60177

Summary * Accomplished Information Technology professional with experience in progressively increasing responsible roles. Developed scalable solutions/databases that improve efficiency, productivity, and profitability across business functions. * Served as a key source in the Administration, Support and Setup of the Association and Membership Management (AMS) ERP software solution (Personify). * Working experience with CRM ...

Tags for this Online Resume: Security, Stored Procedures, Structured Query Language, Support, Capacity Planning, Crystal Reports, Infrastructure, Management, MySQL Database, Planning

Chemical Plant System Operator - 15 Years of Experience - Near 60101

SUMMARY * Bachelor Degree in Science in Biology and has extensive years of laboratory experience. * Adherence to GMP, ISO Standards and OSHA procedures. * Performed PH, percent solids, conductivity, UV/Vis, Gel Electrophoresis, Carl fisher, fill weight as additional testing including simulation runs on the actual diagnostic instruments. * Knowledge / experience in Process Validation, Test Method Validation, Vendor Qualifica...

Tags for this Online Resume: lab tech , R, Safety, Tech Supp Lab Tech, word, Complaints, Distribution, Electrophoresis, Failure Analysis, OSHA, production, maintenance, manufacturing

Quality Manager - 12 Years of Experience - Near 19120

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Integrate, Oracle, Graphical User Interface, Intranet, Microsoft Visio, Microsoft Visio Professional, Microsoft Word, Statistical Analysis, Technical Writer, Documentum, Sharepoint, Trackwise

Electronics Engineer

PROFESSIONAL SUMMARY o Prioritizing and multitasking as and where necessary in fast paced startup along with hands on experience in production line. o Experience in characterizing the antenna and tune it with the matching network elements. o Good experience in IEC 60601-1, IEC 60601-2-25, IEC 60601-2-47 for FDA flow, and ISO standard. o Hands on knowledge in setting up new evaluation modules as per requirement. Ability to r...

Ideal Companies: Aerotek, Raytheon, Eaton

Tags for this Online Resume: Biomedical Industry, CCS, Debugging, Documentation, Ideal, ISO, Packaging, Python Programming Language, Schematics, Security

Engineering Manager

PROFESSIONAL SUMMARY Engineering management professional who offers solid expertise in leading cross functional teams of engineers, project managers, marketing, quality, validations and operations to successfully accomplish projects and corporate goals. Manager with hands on experienced who will deliver outstanding results in new product development, lean manufacturing processes (Toyota Production System), and state of the ...

Tags for this Online Resume: ISO, Machine Design, Pharmaceutical, Autocad, Autodesk AutoCAD, Automation, Engineering, Inventory, Management, MCAD Solidworks

Sr. Sales Executive - 20+ years experience

Products Globe valves Duties: Masoneilan Authorized Repair Centers in the Americas relied on my experience and Decision-making ability to provide them with information and parts in rapid response situations. Coordinated major shutdowns and emergency repairs with representatives and their clients. Responsible for maintaining and developing subcontractors that could respond within our perimeters. Approved warranty for parts a...

Tags for this Online Resume: Automation, Sales, Sales Calls, Honeywell, Direct Sales, Biomedical Industry, Corporate Training, Electronics, LMS, Manufacturing, Control Valves, Application Expert, Houston, Texas, Downstream, Midstream, Sales, Business Development, inside sales, Control Valves, Instrumentation, Actuators

Quality Manager

Qualifications * 15 years experience in sheet metal manufacturing, assembly and distribution * Experienced in precision machining inspection and operations * Experienced in Fiber Glass * Experienced in ISO standards and criteria * Trained in Lean Manufacturing and 5S Organization

Tags for this Online Resume: Corrective Actions, Auto Body Repair, Inventory, CIS (Ibm Customr Info Sys), ISO, ISO 9001, Management, PMP, Process Improvements, Quality