CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "CAPAs"

Quality Manager - 16 Years of Experience - Near 30038

SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...

Tags for this Online Resume: Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans

Plant Manager - 15 Years of Experience - Near 72000

Career Summary A challenging position and active involvement in a progressive organization offering the opportunity to fully utilize proven and developing skills. Summary of supportive Qualifications * 15 years of experience in Quality Assurance/Quality Control/Quality System * Excellent skills in Quality processes, Design Concepts (Risk Management) and Problem Solving. * Regulatory compliance (FDA QSR, CMDR, IS013485, MDD....

Tags for this Online Resume: Quality Assurance, Audit, Medical, Compliance, DFMEA, Documentation, manufacturing, ISO13485, Plant Management, Test, Quality Assurance Medical Device

Quality Engineer - 5 Years of Experience - Near 91343

SUMMARY OF PROFESSIONAL EXPERIENCE: * Hands on experience on all kinds of environmental Test, EMI & ESD Test for 12 years. * Extensive experience in Electro Mechanical Environmental Test including Design Validation and Product verification for Automotive, Aerospace equipment, Electronic Device (iPhone) &Medical Device. * Hands on working Experience on All kinds of Valve and actuator for Aerospace & Automotive Industry 8 yea...

Tags for this Online Resume: Automotive, Process Improvement, Data Management, Management, Manufacturing, SAP, PPAP, APQP, Lean Manufacturing, Aerospace, Quality Eng, Suppliers Quality Engineer, manufacturing, "project management", production

Quality Manager - 10 Years of Experience - Near 96

ACCOMPLISHMENTS * Efficiently conducted DO IT RIGHT Daily Rejection Analysis with CAPA Weekly & Monthly Pareto for Rejection * Deftly resolved customer complaints pertaining to quality & performance through (PSS) Problem Solving Sheet (8D Methodology) * Rendered Customer Quality Support to OE customers for field issues within warranty and 0-km traded parts SKILL ENHANCEMENTS * ISO 9001 - 2008 TS-16949: Veer-o-Metals Pvt. Lt...

Tags for this Online Resume: Quality, ISO, Quality Assurance, Test, VMS, CMM (Capability Maturity Model), Electronics, Mts (Microfocus Trans), OE and Organizational Effectiveness, Problem Solving

Quality Engineer - 15 Years of Experience - Near 10312

Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...

Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst

Product Quality Leader - 20 Years of Experience - Near 32937

To obtain a challenging position in a high quality engineering environment where my resourceful experience and academic skills will add value to organizational operations.

Tags for this Online Resume: HVAC, Protocol, ISO, ISO 9001, Management, Inventory, Transportation, Electronics, Failure Analysis, QMS, Root Cause Analysis Leader, ISO 9001 Lead Auditor, CAPA, Lean Six Sigma BB, Supplier Quality, PCB Reliability, Quality Leader, PCB Assembly, Lean Six Sigma GB Instructor, Counterfeit Components

General - 16 Years of Experience - Near 06443

A multi-disciplined, results driven, and goal oriented quality management leader with over twenty years of experience in the regulated pharmaceutical industry. A diverse background that includes all aspects of Quality Assurance (QA) management, Information Technology (IT), and project management. A customer focused and self-motivated team player with a history of working as a leader in team-oriented environments. Success...

Tags for this Online Resume: Auditing, Computer Systems Validation, CAPA, Quality Systems, Research and Development, Pharmaceutical Biotech, Auditing, Quality Management, Computer Systems Validation, CAPA, Supervision, GMP, 21 CFR Part 11, Quality, Quality Assurance, Good Laboratory Practices, Software Quality Assurance, Software Validation

Quality Coordinator - 20 Years of Experience - Near 18353

Areas of Expertise & Technical Skills * Regulation Compliance * Agile (Scrum Master) * Internal/External Audits * Batch Record Reviews * CAPA / Risk Management * QA System Management & Implementations * Project Life Cycle * Technical Writing * Process Improvements * Six Sigma (Green Belt) * Document Controls * Software Implementation * CFR 210/211/820/803/58/11 * Team Training & Development

Tags for this Online Resume: Audit, Business Contingency Planning, Compliance, Documentation, Good Manufacturing Practices, Manufacturing, MDR, Packaging

Software Engineer

Quality orientated Biochemist and Software Engineer who resolved CAPA, developed medical instrument software requirements and assays, and supervised and trained colleagues. Certified Scrum Master. Wrote and performed verification/validation black box/white box software testing with consideration for User Design and FDA regulations. Solved hardware and software issues. Built and maintained effective working relationships wit...

Tags for this Online Resume: Chemistry, Protocol, Regression Testing, Test, Test Cases, Diagnostics, Design Documents, Microsoft, Software, Unix, SCRUM Master, Agile software development, FDA regulatory, UX design

Department Manager - 20 Years of Experience - Near 79925

SUMMARY: Since 1991 Juarez, MX / El Paso, TX in the Manufacturing Automotive Industry * Bilingual: English/Spanish * Production/Manufacturing * NAFTA/FTZ Process * Project Management * Program Management * Materials (MRP/ERP) * Human resources * Quality * VA/VE * PFMEA * Poke Yoke * APQP * OSHA * Six Sigma Black Belt * Kaizen * Lean Manufacturing * Microsoft Office Tools * Statistical Tools * QS 9000 * ISO 14001 * ISO/TS 16...

Tags for this Online Resume: Black belt, Human Resources, ISO, MFG-PRO, Six Sigma Quality, Training, manufacturing, production, "project management", reliability, Continious Improvement, Budget, New operations launch

Manager - 20 Years of Experience - Near 43016

QUALIFICATIONS Project Management: Ability to plan, communicate, coordinate and execute special project activities and packaging design, sourcing, testing and phase-in events effectively with customers, associates and the supply chain. Supply Chain Management: Manages product sub-suppliers and packaging suppliers and fabricators to meet company goals and objectives. Mitigates problems and drives speedy corrective action as ...

Tags for this Online Resume: Management, Automotive, Customer Service, Distribution, Inventory, Inventory Control, Material Control, OE and Organizational Effectiveness, Test, Packaging

Clinical In-house Monitoring - 4 Years of Experience - Near 95131

Tags for this Online Resume: Documentation, Protocol, Audit, Good Clinical Practices, ICH, Management, Quality Assurance, Test, Quality, Quality Control, oncology, clinical, phase, trial, gcp, protocol, pharmaceutical, SOP, CAPA, Regulation, ich, Monitor, Clinical research, Clinical Trial