CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "13485"

Engineer - 20+ Years of Experience - Near 93010

Summary 20+ years' experience in Aerospace, Military, Medical, and Commercial Engineering and Design: Mechanical, Manufacturing, and Quality Engineering (AS9100 Rev C, ISO 9001, NADCAP, ISO-13485, ANSI/ESDS20.20, IPC-610 Certified) involving PCBAs, system integration, Electro-mechanical packaging, precision mechanism design, Manufacturing, and Facilities lean layouts. Six Sigma Green Belt Certification. ASQ Member (Channel ...

Tags for this Online Resume: Manufacturing, Documentation, Medical, Process Improvements, Quality, Quality Assurance, Engineering, Engineering Drawings, Failure Analysis, AS9100, AS9102 FAIR, ISO13485

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

Quality Manager - 20 Years of Experience - Near 37064

Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...

Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions

Quality Assurance Specialist - 20 Years of Experience

Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....

Tags for this Online Resume: Data Analysis, Medical, Complaints, Quality, Risk Analysis

Operations Manager - 20 Years of Experience - Near 01886

Summary * Over 25 years of experience in high technology including electrical, electro-mechanical, optical and contract manufacturing assembly. * Have held key positions at various levels throughout my career. These included engineering management, sales and marketing, program and operations management. * Strong innovative leader with excellent planning, communication and team building skills. * Self-motivated, hands-on ind...

Tags for this Online Resume: Voice, Distribution, Sales, Logistics, Manufacturing, Professional Services, Services, Supply Chain, Lean Manufacturing, Solder

Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

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

Not Listed - 17 Years of Experience - Near 53562

Areas of Expertise * Quality Engineer * Non-Conformance * Auditing * Product Surveillance * Training & Staff Development * Medical Device & Pharma * Complaint Review * Policy & Procedures * FDA/MDR Reporting * Subject Matter Expert * Complaint Investigation * 21CFR Part 210 and 211 * 21CFR Part 820 and 803 * ISO 9001, 13485 & 14001 * Laboratory Testing * Calibration and Validation * Federal Compliance * International Compli...

Tags for this Online Resume: Quality, Quality Assurance, Systems Operations, Documentation, Instrument Calibration, Notebook Computer, Project Coordinator, Process Improvement, Typing, Inventory, human resources

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