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Online Resumes with "CAPA Management "



Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Vice President - 20 Years of Experience - Near 33076

VP / Director – Global Operations, Quality, Supply Chain or Programs

Tags for this Online Resume: Due Diligence, Supply Chain, Distribution, Manufacturing, Program Manager, S&OP, ERP, CRM, Strategic Deployment, NPD/I, Global commercialization, Financial Management, Lean (TPS), Six Sigma, OPEX, QMS, CAPA Management, FAA, FDA, DFx, Change management, organizational development, Multi-site Inventory & Facilities, M&A, Life Cycle Management, Design Control

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

Quality Assurance Director - 20 Years of Experience - Near 92131

Summary Extensive strategic management development, deployment and execution supporting C-level, SVP and Sr. Management leading regulatory action remediation projects, coaching sponsors, key stakeholders and teams through containment, control, and compliance driving sustainability goals for Life Science companies in Biotechnology, Pharmaceuticals, Medical Device and Combination Products, addressing process improvement initi...

Tags for this Online Resume: Director Quality Assurance, Director Regulatory Affairs, Senior Project Manager, Director PMO, ISO, Software, Software Development, Quality Compliance, Director QARA

Department Manager - 17 Years of Experience - Near 61104

PROFESSIONAL SUMMARY Self-motivated, dedicated and reliable professional with proven experience as packaging mechanic, supervisor, lead technician and technical trainer solid experience with multiple operating systems. Supervior: Lead Technician: Provide troubleshooting expertise, preventive maintenance and repair of integrated packaging lines in a cGMP environment ensure compliance with standard operating procedures (SOP)....

Tags for this Online Resume: maint, Preventive Maintenance, Leadership, Packaging, Reliability, Management, Pharmaceutical, Project Management, Support, maintenance

Department Supervisor maintenance - 17 Years of Experience - Near 61104

PROFESSIONAL SUMMARY Self-motivated, dedicated and reliable professional with proven experience as packaging mechanic, supervisor, lead technician and technical trainer solid experience with multiple operating systems. Supervior: Lead Technician: Provide troubleshooting expertise, preventive maintenance and repair of integrated packaging lines in a cGMP environment ensure compliance with standard operating procedures (SOP)....

Tags for this Online Resume: Preventive Maintenance, Leadership, Packaging, Reliability, Management, Pharmaceutical, Project Management, Support, Training, Troubleshooting, maintenance

Mechanical Inspector - 15 Years of Experience - Near 61104

PROFESSIONAL SUMMARY Self-motivated, dedicated and reliable professional with proven experience as packaging mechanic, supervisor, lead technician and technical trainer solid experience with multiple operating systems. Supervior: Lead Technician: Provide troubleshooting expertise, preventive maintenance and repair of integrated packaging lines in a cGMP environment ensure compliance with standard operating procedures (SOP)....

Tags for this Online Resume: Leadership, Packaging, Reliability, Pharmaceutical, Project Management, Support, Training, Troubleshooting, Preventive Maintenance, CMM (Capability Maturity Model)

Director - 23 Years of Experience - Near 28079

Summary Ambitious Sr. Manager with more than 23 years of management experience in Manufacturing/Distribution/Logistics/Repair & Refurbishment environments. Applies strong analytical and critical thinking skills to solve complex operational problems. Ability to direct complex projects from concept to fully operational status, goal-oriented individual with strong leadership capabilities and a passion to succeed. Ability to st...

Tags for this Online Resume: Distribution, Process Improvements, Logistics, P&L, Configuration Management, Configure, IBM, Management, Services, Telecommunications

Compliance Officer

Professional Summary Dedicated Operations and Quality Manager demonstrating effective leadership in all aspects of the job, excels at cutting costs and streamlining operations. Career has incorporated positions of increasing management and leadership over new product development, quality engineering, regulatory affairs, and complaint and CAPA management which is built on a foundation of clinical patient care and customer su...

Tags for this Online Resume: Quality Assurance, Engineering, Orthopedic, Orthopedics, Quality, Sales, Sourcing, ISO, Planning, Development Activities

Manager

Professional Summary Dedicated Operations and Quality Manager demonstrating effective leadership in all aspects of the job, excels at cutting costs and streamlining operations. Career has incorporated positions of increasing management and leadership over new product development, quality engineering, regulatory affairs, and complaint and CAPA management which is built on a foundation of clinical patient care and customer su...

Tags for this Online Resume: Quality Assurance, Orthopedic, Orthopedics, Quality, Sales, Sourcing, Engineering, Planning, ISO, Management

Quality Engineer

Professional Summary Dedicated Operations and Quality Manager demonstrating effective leadership in all aspects of the job, excels at cutting costs and streamlining operations. Career has incorporated positions of increasing management and leadership over new product development, quality engineering, regulatory affairs, and complaint and CAPA management which is built on a foundation of clinical patient care and customer su...

Tags for this Online Resume: Quality Assurance, Engineering, Orthopedic, Orthopedics, Quality, Sales, Sourcing, ISO, Planning, Development Activities

Featured Profile

Manufacturing and Operations Leader

Highly adept business leader with a strong track record of successful change management in manufacturing and engineering based organizations. Demonstrated ability to excel in management roles with progressive responsibility. Robust background in all areas of Operations management with over 20 years of experience focused on NPI, Lean deployment, site transfers, cost reductions, and QMS compliance. Energetic, people-oriented...

Ideal Companies: Medical Device manufactures

Tags for this Online Resume: Change Management, Coaching, Engineering, Kaizen, Leadership, Management, Manufacturing, Manufacturing Engineering, Medical Devices, Inventory Management, Business Process Improvement, Lean, Continuous Improvement, Quality System, Supply Chain, Warehousing, Process Management, Budget Management, Organizational Develpment, Servant Leadership, Cost Savings, Capital Acquisitions, Plant Leader