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Online Resumes with "13485"
Project Manager - 20 Years of Experience - Near 91302
SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems...
Tags for this Online Resume: Database, Database Design, Integrate, Business Requirements, Javascript, BASIC Programming Language, FACETS, Hospital Information Systems, HyperText Markup Language, Legacy, Project Management, Agile, Scrum Master
Quality Engineer - 4 Years of Experience - Near 80918
Summary of experience Extensive experience in Medical Device Design, Development and Manufacturing Quality: New product Design experience: 10 new product design projects, and over 30 product redesign projects Design Input: VOC, Risk Analysis (HA & dFMEA), MRD, DRD Design Output: Verification & Validation testing (ex - & in-vivo, human factors & clinical) Mfg. Qualification experience: IQ/OQ/PQs, DOEs, MSAs, GR&Rs Six-Sigma ...
Tags for this Online Resume: Product Development, Reliability, Evaluate, Product Development, Quality Assurance, Reliability, MicroElectronics, Silicon Wafers, Test, DFMEA, Quality, Quality Engineering, Medical Device, Medical device product development, Continuous Improvement, Supplier Quality, project engineer, project manager
Quality Manager - 20 Years of Experience - Near 12534
SUMMARY OF QUALIFICATIONS: Over 25+ years experience in the field of Quality Assurance compliance in a wide variety of analytical laboratories and production settings. Specialization in regulated Quality Assurance manufacturing, compliance testing, packaging, labeling, and distribution of a variety of products.
Tags for this Online Resume: Auditing, Manufacturing, Quality Assurance, Technical Writing, Quality Control, Packaging, Testing, CAPA, Customer Complaints, Documentation, ISO 9001, ISO 13485, "project management"
Quality Manager - 20 Years of Experience - Near 28269
Summary of Qualifications and Accomplishments * Demonstrated excellent Quality Management/ Engineering work experience, providing technical support to customers, suppliers, cross-functional team members, and manufacturing on new and existing products. * Knowledgeable and experienced with SMT, PTH, Hybrid, Chip on Board, Power Supply, and Fiber Optic technologies to assemble, test, and box build printed circuit boards in sup...
Tags for this Online Resume: ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering, ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering
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
Engineering Manager
ACCOMPLISHMENTS * Drove development of new products which allowed the growth of Titan Spine from around $1M annual sales to over $30M in 7 years. * Participated (on a team of 3) in achieving ISO 13485 certification of Titan Spine in 6 months. * Named as inventor on 38 United States Patents for medical devices. * Lead the development and launch of the Charlotte™ Foot and Ankle product line which is the foundation of the extr...
Tags for this Online Resume: Distribution, Medical, Medical Technology, Sales, Management, Packaging, Product Development, Product Launch, Surgical, Development Activities, mechanical engineering, project engineer, orthopedics
Microbiologist - 20 Years of Experience - Near 07753
Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...
Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap
Scientist - 20 Years of Experience - Near 92620
SUMMARY Medical device management professional (MS, MBA) with leadership experience in Stage Gate Product Development Process (PDP), Class I, II and III devices, Systems Engineering, Design Control, Quality Systems Requirements, clinically relevant strategic roadmap creation, capital equipment, IP portfolio management, market-driven technology development, product development, business development, project management, drug/...
Tags for this Online Resume: Business Development, PET, Therapy, Diversity, ISO, Management, Orthopedics, Product Development, Trauma, Cardiovascular, Medical Device leadership
Quality Manager/Director - 25 Years Experience - Desire relocation to Nashville, TN
I am a scientifically trained quality professional with over 25 years of experience. As a former military officer, I bring leadership and communication skills and a passion for customer satisfaction and organizational improvement and success. I am a team builder and operate with a hands-on approach.
Tags for this Online Resume: Quality Management, ISO 9001, ISO 13485, Communication Skills, Process Improvement/6 Sigma, Validation, Problem Solving, Science, HYGIENE, Test, Acceptance Testing, Protocol, Quality, Quality Assurance
Quality Manager - 20 Years of Experience - Near 45342
a challenging position utilizing my skills in Quality/Document Control, NEI Six Sigma tools, and Engineering. I feel my experience and background in quality, engineering, and manufacturing are a good fit for a position within your company. We have recently re-located to the Maimisburg area. Advanced Forming Technology: 1992 - 2017 QUALITY ANALYST 2008 - 2017 Responsibilities, Duties and Accomplishments * Company representat...
Tags for this Online Resume: Enterprise Requirements Planning, SAS/STAT, Training, Document Control, QMS Lead Auditor, manufacturing, Document Controller, Quality trainer, Supplier/Vendor auditor, Quality Analyst, RMA tracking
Quality Engineer
Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...
Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis
Department Manager - 20+ Years of Experience - Open to Relocation
Qualifications: * Goal-driven Servant Leader with broad experience in Quality Technology, Manufacturing, and Lean Initiatives. * Demonstrated record of high performance standards, including attention to schedules, deadlines, and issue resolution with an emphasis on the bottom line. * An effective leader with solid decision making capability and dedicated to "Sending the Right Message". * Ability to effectively lead multiple...
Tags for this Online Resume: Architect, Manufacturing, ISO, ISO 9001, Management, Microsoft PowerPoint, Quality, Quality Assurance, Quality Management, Development Activities
