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Online Resumes with "quality systems development"



Quality Manager - 20 years experience

I am a Quality Manager with extensive expertise that has produced results in supplier development, process evaluation, testing procedures, and quality systems development for KEIPER, LLC. I have acquired significant experience with a proven track record in the quality arena. I am fluent in the lean/sigma tools, and lead many continuous improvement events. I also have experience in the implementation and compliance of cu...

Quality / Process Engineer with 11 years of manufacturing experience in leadership roles

I am seeking a company which offers growth potential into a management position. My background is strong in the areas of trial leadership, six sigma process improvements, and quality systems development.

Production/Manufacturing Supervisor

Strong organizational skills, comfortable in complex manufacturing environment. Skilled in operational management, time study and standard work, quality system development, safety, and human resources. Leadership, management and employee training in composites manufacturing and in job site operation environments. Certified as a composites technician

Pharmaceutical Consultant

Certified Medical Technologist. Solutions-oriented candidate offering 10+ years of combined experience in pharmaceutical, global clinical trials, strategy, and process management. Broad experience in eliciting client requirements, including interviews/meetings, and document analysis of global quality systems for development of commercial pharmaceutical activities. In-depth knowledge of regulatory compliance, drug safety sy...

Tags for this Online Resume: Research, Biotech, Pharmaceutical, Clinical, Laboratory, Science

Featured Profile

Program, Quality and Regulatory Manager

Experienced Quality Manager with a proven record of developing the methodologies and tools to help companies manage organizational change, meet customer requirements and provide product excellence. Has extensive project team and department management experience in Quality Management and Regulatory Engineering, primarily for information systems, telecommunications and medical applications. Highly analytical, dynamic, resul...

Ideal Companies: Juniper, Tellabs, Sonus, Sycamore, Wyeth, Phillips, Siemans

Tags for this Online Resume: Program and Project Management, Business Analysis/Process and Data Analyst, Software Quality Assurance (SQA),, Requirements Management, Configuration Management, Defect Management, Quality Systems Development and Quality Management, Business Process Vision and Policies, Organizational Development and Re-engineering, Business Systems Requirements Specification, Course Development and Technical Training, Process and Training Documentation and Technical Writing, Product Design and Qualifications (power and packaging), Component Engineering (analog and materials), European and Asia Pacific business experience, Data Base Development and SQA, Use Case Modeling, Requirements and Defect Management, Issue Management, Document Management, KPI Definition, Analysis and Business Process Improvement, Use Cases Development, Test and Training, Internal Audit Planning, Implementation and Management, Hardware and Software PLC Management, Software Development Life Cycle (SDLC), Product Safety, EMC, EMI Environmental Management, Manufacturing, Customer and Field Support, Standards and Regulatory: UL, CSA, IEC, ISO, VDE, BSI, KEMA, FCC, FDA, PTT, BABT, OSHA, NEC, Sarbanes-Oxley (SarbOx/SOX), COBIT, Standards Making Committees: ECMA TC12, CBEMA ESC2, TIA, Process Frameworks: ISO 9000:2000 and TL 9000 (cGMP/QS9000 equivalent), CMMI, ITIL, SWBoK, PMBoK, RUP, and Sarbanes-Oxley compliance, Mass Quality Award/Baldridge Evaluation/Implementation, ODI and Rummler-Brache Process Improvement Methods, Metrics and Tools: TQM, SPC, TL9000 and GR-929 metrics implementations and Six Sigma tools and methodologies

Competent and highly dedicated professional with experience in quality assurance, manufacturing, projects and, research & development. Contributed to the success of the last two companies he worked at. Both companies manufactured edible oil, other food

Go back to work to continue my career as a process, manufacturing, quality or project engineer in a progressive chemical or food manufacturing company

Tags for this Online Resume: Food Engineer, Process Engineer, Manufacturing Engineer, Quality Engineer, Research

Quality Assurance Associate Managert

Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...

Tags for this Online Resume: Quality Assurance, FDA regulations, CAPA, Document Control, Change control

Compliant, but flexible...the best of both worlds

I am primarily interested in obtaining a VP position and using my knowledge to truly direct and enhance a companies experience with quality systems and to provide their customers with products that meet or exceed customer expectations.

Ideal Companies: Medical Device Manufacturers

Tags for this Online Resume: Quality Assurance, Project Management, Auditor, ISO 13485:2003, 21 CFR 820, QSR, Regulatory, Management, Medical Devices

Director of Quality

Tags for this Online Resume: Regulatory Compliance, Quality Systems Development and Implementation, Equipment/Process validations, Design control Final Approver, Managing Operations in 4 countries, Management Representative

Featured Profile

Laboratory and manufacturing manager with ISO 9001, 17025, cGxP, C.I. and method/process validation experience

To find a position utilizing some or all of the following competencies: • Food, drug, medical device, and consumer goods manufacturing experience. • Skilled QC analytical/R&D laboratory manager w/10 direct reports. • ISO 9001/17025 compliance experience in manufacturing environment. • Laboratory quality system development and cGMP writing and auditing. • Continuous Improvement and metrics monitoring experience. • Deve...

Ideal Companies: Boston Scientific, Johnson and Johnson (JnJ), Altria, RJ Renoylds, Airgas

Tags for this Online Resume: Quality Assurance, Chemical Analysis Manager, Laboratory Manager, Analytical Laboratory Manager, Plant Manager, Medical Device Scientist

Quality Systems Manager - 18+ yesrs experience - Conecticut - CAPA - Supplier Quality - Receiving Inspection = Supplier Certification - Supplier Audits - Clean Room - ISO 9000 - ISO 13485 - Internal Audits - External Audits - Regulatory Audits - Change Ma

Twenty five years of experience in areas related to the Quality Systems, Manufacturing, Calibration, and Project Management. Experienced in Manufacturing Management, Quality Systems development, maintenance and improvement, New Product Introductions and Product Transfers, Supplier Quality Management, budgeting, outsourcing, and Validation Protocols in a Medical Device manufacturing environment. Data driven with excellent...

Tags for this Online Resume: Connecticut, Supplier Quality, Quality Systems, Quality Manager, ISO13485, Medical Device