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Online Resumes with "quality Regulatory"



Clinical Quality Assurance - 16 Years of Experience - Near 30601

A highly efficient, methodical and talented quality assurance analyst who has more than 16 years’ experience in the field of process control, quality and regulatory fields and QA/QC analytical systems. I have considerable experience of developing and implementing effective quality control processes and structures in a manufacturing and corporate environment. Possessing good essentials of safety and quality. Strong customer ...

Tags for this Online Resume: QUALITY ASSURANCE, pharmaceutical, documentation, 21 cfr 210-211, sop, fda, batch record review, audit

Mechanical Engineer - 20 Years of Experience - Near 19255

To apply my engineering, manufacturing, quality, regulatory and environmental experience, to implement innovative product design and process development in a Functional, Project or Environmental Management position.

Tags for this Online Resume: Pennsylvania, Policy Deployment, SAP, Problem Solving, Product Development, Kaizen, Standard Work, PMP

Featured Profile

Quality and Operations Excellence Professional

An opportunity to create long term sustainable value for a company through facilitating a culture of risk management and process optimization

Tags for this Online Resume: Quality, Operations Excellence, Compliance, ISO, CGMP, Product Stewardship, Quality engineer, Auditor, Process Management

Quality Assurance Director - 20 Years of Experience - Near 44095

Accomplished business professional with extensive experience in Quality and Regulatory for Medical Devices, Engineering and Design. Possess proficient skills in the numerous areas.

Tags for this Online Resume: Cleveland, OH, Supplier Quality, Quality Assurance, FDA, ISO13485, Clinical monitoring, RAB auditor, Documentation, Reliability, ISO, Integrated Development Environments, Licensing, Quality, Rehabilitation

Quality Engineer Manager

Julie is a Quality Management leader with the vision and insight needed to provide strategic direction and ensure systemic quality and regulatory compliance. Through the application of Lean-Sigma practices she brings improved manufacturing process capabilities and increased efficiency. She is a superb team facilitator who demonstrates excellence in communication skills at all levels by providing meaningful feedback to emplo...

Tags for this Online Resume: 21 CFR 820, Supplier Quality, Quality Management Systems, Global, Process Analysis and Improvement, Lean Sigma Green Belt, Certified Lead Auditor, ISO 9001, 13485, 14001

Biostatatician

SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...

Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical

Production Manager - 18 Years of Experience - Near 02725

SUMMARY Eighteen years experience in Manufacturing or Manufacturing support, including over ten years of supervisory experience. Proven ability to drive production against aggressive schedules while rigorously maintaining safety, quality, and regulatory standards. Expertise in training, documentation, and technical transfer functions. Familiarity with Lean Manufacturing and continuous improvement initiatives. Extensive expe...

Tags for this Online Resume: Documentation, Good Manufacturing Practices, Support, Compliance, Housekeeping, Management, Utilities, Evaluate, Kaizen, Lean Manufacturing

Case Manager, HIV Consultant in East Africa, Public Health Nurse, Ambulatory Care, Nurse Educator

KEY QUALIFICATIONS: 8 years case management at major health insurance company in Boston Clinical nursing:, critical care, rehabilitation, home care, HIV/AIDS Nurse management and supervisory responsibilities in rehab center Public health and nutrition coordinator in East Africa Designed, developed and managed administrative infrastructure of Graduate Medical Education Residency program in East Africa Reviewed, coordination ...

Tags for this Online Resume: Management, Medical, Compensation, Health Care Industry, Orthopedics, Rehabilitation, Scheduling, quality issues, research, ambulatory

Quality and Regulatory Compliance

SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...

Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services

Engineering Manager

QUALIFICATIONS Director of Operations and Engineering, Chief Technical Officer, Sr. Principal Research and Development Engineer as well as Sr. Principal Process Engineer strong background in several engineering disciplines as well as business, quality and regulatory experience More than 20 years of experience in Engineering Research and Development, New Product Development, production process/manufacturing integration as we...

Tags for this Online Resume: New Product Developmement, Research and Development, Satellite Engineer, Radar, Director, Space and Flight Systems, Engineering Manager, Ultrasound Engineer, Satellite Systems, Chief Technical Officer, Senior Principal Engineer, Electrical Engineer, Senior Scientist, Director of Engineering, Director of Operations

Featured Profile

Clinical Regulatory Affairs - 20 Years of Experience - Near 53143

Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...

Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices

Manager - 20 Years of Experience - Near 77433

facility Provided operational and manufacturing leadership to APD team in the areas of design for manufacturability, process development and training, manufacturing and pilot builds, cell layouts, kaizen events, quality documentation and all other manufacturing deliverables. -Worked collaboratively with quality, regulatory affairs, DBS, and all operating divisions to develop operations budget and timeline, address pre-launc...

Tags for this Online Resume: Management, Manufacturing, Siemens, Audit, PMI, Documentation, Kaizen, Lean Manufacturing, Legacy, 5S