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Online Resumes with "Medical Device Directives"
I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.
I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.
Ideal Companies: Stable
Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager
Sr. Mechanical Engineer, Philadelphia
Apply innovative engineering concepts, medical and industrial product development expertise and attention to detail.
Tags for this Online Resume: Solidworks 3D and 2D, Plastics injection molding, Finite element analysis, Medical Device Directives, Solidworks 3D and 2D design, 9 US Patents, Innovative Concepts and Design
QC/QA/RA Supervisor - over 25 years experiences in Medical devices
Offering extensive experience in quality control and manufacturing of medical devices. Directed and coordinated all inspection and test activity (incoming, in-process and final). Controlled and maintained all device history records. Participated in MRB,ISO and customer audits. Working knowledge of geometric dimensioning and tolerancing, electrical/mechanical assemblies.
Biological Science Teacher - 11 Years of Experience - Near 79932
I am seeking an opportunity to advance my career as a Tenured Professor with a college that is aligned with my teaching philosophy. I believe that the student is the most important and each student has different levels of learning and challenges. Therefore, it is necessary to be flexible and able to identify the different types of students and apply necessary teaching techniques for the success of the student.
Ideal Companies: 2 or 4 year Colleges
Tags for this Online Resume: Biology, Professor, Community College, El Paso, Neuroscience, Microbiology, Anatomy , Pathophysiology
Director of Quality - 15 Years of Experience - Near 77086
10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.
Tags for this Online Resume: Quality Systems, Medical Device, Regulatory Affairs, 510K submission, CE Mark, Consultant, Director, Vice President
Quality Manager - 10 Years of Experience - Near 28314
PROFILE Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized...
Tags for this Online Resume: Quality Assurance, Test, Aerospace, Defense, ISO, Medical, Audit, Automotive, Complaints, Packaging, Quality Engineer
Quality Manager - 17 Years of Experience - Near 60051
SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...
Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management
Health Technologist - 0 Years of Experience - Near 11746
SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...
Tags for this Online Resume: Management, Medical, Operating Room, Policies and Procedures, Project Management, Rf, Software, Software Development, Surgical, Test
Quality Professional
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Electrical Engineer - 11 Years of Experience - Near 10930
Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...
Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery
Quality Manager
CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...
Tags for this Online Resume: Process Control, Management, SPC, ISO, Policies and Procedures, Project Management, Project Manager, Quality, Quality Assurance, Quality Management
