CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "iso13485"

Process Engineer - 15 Years of Experience - Near 55376

To benefit an organization that can use a knowledgeable Six-Sigma Black Belt Quality Manager with a proven ability to continuously improve processes/customer satisfaction and supplier development while building a strong project team, and strengthen customer relation using various Six-Sigma/Project Management tools and methodologies. Responsibilities: ISO 13485, 14971 Managing/Directing quality staff. Supervising/ Mentoring ...

Tags for this Online Resume: Audit, Data Analysis, CMM (Capability Maturity Model), Management, Product Development, Reliability, Stents, Heat Treating, Plastics, Msa (Accounting Pkg)

Quality Engineer - 13 Years of Experience - Near 92630

I enjoy working with start-up or multi national/ global medical device companies. Apply my experience in mechanical engineering to design & development, remediation projects for class II medical devices.

Tags for this Online Resume: Product Development, Manufacturing, Medical Devices, Product Design, Training, Documentation, Packaging, Test, "project management", production, mechanical engineer, Project Engineer, USFDA 21 CFR (QSR), ISO 13485 (QSR), ISO 14971 (Risk Mngt), MDD/93/42/EEC, QA Engineering, Contract Eng. Start-up & Multi National/Global

Engineering Manager - 14 Years of Experience - Near 92563

Career Summary My current job is Verification & Validation (V&V) Manager for UNICO Engineering for the California High-Speed Rail project. I am responsible for the requirement database, V&V status reporting, and requirements traceability and management for California Rail Builders. I also possess considerable experience with ISO 13485-QMS for medical devices standard and ISO 1497-medical device risk management. My backgroun...

Tags for this Online Resume: Account Manager, Logistics, Quality Assurance, Test, Acceptance Testing, Integrate, Manufacturing, Assessments, Critical Care - Vascular, Green Belt, siemens

Production Manager - 20 Years of Experience - Near 01702

Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...

Tags for this Online Resume: Lean Manufacturing, Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical, Purchasing, Quality Assurance, manufacturing

Quality Assurance Director - 20 Years of Experience - Near 92336

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: Documentation, Management, Project Management, Pharmaceutical, documentation control, documentation management, quality systems

Biomedical Engineer - 14 Years of Experience - Near 92563

Career Summary My current job is Verification & Validation (V&V) Manager for the California High-Speed Rail project. I am responsible for managing the requirements database, V&V status reporting, and requirements traceability for the California Rail Builders. I possess considerable experience with ISO 13485 Quality Management System for medical devices standard and ISO 14971:2012 Medical Device Risk Management. My backgroun...

Tags for this Online Resume: ISO, Acceptance Testing, Account Manager, Integrate, Logistics, Manufacturing, Services, Test, Assessments, Critical Care - Vascular, electronics, Metrology

Biochemist - 18 Years of Experience - Near 44202

Professional Summary I have over ten years of experience in the Biotech industry in both Research and Development and Quality Control). Accomplishments/Skills Technical experiences skills including: * Protein purification using anion exchange, affinity, HIC and SEC as well as HPLC. * Operation of an Agilent and Water's HPLC * Operation of the GE AKTA and Bio-Rad NGC FPLC systems * Cloning and expressing proteins in E. coli....

Tags for this Online Resume: Process Improvement, Troubleshooting, High Performance Liquid Chromatography (HPLC), Quality Control, Research, Manufacturing, Protein Purification, Protein Analysis, ELISA Assay, Western Blot analysis, qPCR/PCR, Cloning, cGMP

Quality Manager - 20 Years of Experience - Near 93030

To expang my knowledge and also teach others on Quality Standards, Processes, and Techniques for better flow.

Tags for this Online Resume: Quality, SPC, ISO 13485, ISO 9001, ASQC, ANSI Y 14,5, CA., Quality Assurance, Quality Control, CMM (Capability Maturity Model), manufacturing

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

PROJECT MANAGER

Career Summary * Over a decade of experience with medical device manufacturing, inclusive of the following: * Project Management, specifically New Product Development * Design Engineering and Control * Manufacturing Engineering and Six Sigma Manufacturing * Process Development and Statistical Process Control * Quality Management, Testing, and IQ/OQ/PQ Validation * Regulatory Compliance and GMP (FDA Class I, II, and III devi...

Tags for this Online Resume: Billing, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, Program Manager, Quality, PROJECT MANAGER, PROJECT ENGINEER, MANUFACTURING ENGINEER, MEDICAL DEVICE MANUFACTURING, REGULATORY COMPLIANCE, DESIGN & DOCUMENTATION, OPERATION MANAGEMENT, SALES & MARKETING

Clinical Quality Assurance - 13 Years of Experience - Near 92057

QUALIFICATIONS: Over 13 years of experience in the Pharmaceutical and Medical Device Industry. I have a proven desire to enhance team effort and first time quality concepts, Strong creative research skills, Strong detailed and task oriented skills. Work environment regulated by 21 CFR 820 and ISO 13485:2003 & 9001. Specialized in Quality Assurance, Regulatory Compliance, GMP, Document Control, QSR training, Excel, Power Poi...

Tags for this Online Resume: Compliance, Accounts Receivable, Customer Service, Inventory, ANSI, Ansi (Am Natl Stds Inst), Training, Audit, Document Control, ISO

Director of Quality

Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12 of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, project-management and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...

Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management