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Online Resumes with "MDD "
General - 7 Years of Experience
KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/E...
Tags for this Online Resume: Complaints, Good Clinical Practices, Medical, Pharmaceutical, Support, Technical Support, Clinical Research, Project Management, Project Manager, Research
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
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
Sales Manager - 18 Years of Experience - Near 92694
Leadership: • 20+ Years: Pharmaceutical Experience • 18 Years: Sales and Account Management Experience Sales Performance: • 9 President's Club / President Circle (Top 10%) Annual Awards • 6 of last 8 Years in the Top 20% in the Nation, as a Specialty DSM • #2 of 165 Districts in the Nation: Top Market Share selling Top Branded MDD agent: Trintellix o This is the Top 1% in the Nation Diversification: • RAM (Regional A...
Tags for this Online Resume: DMS, Dms (Data Mgmt Tool), Gastroenterology, Sales, Billing, Capital Equipment, Chemistry, Consulting, POD, Account Manager, sales, outside sales, account executive, business development, account manager
Quality Assurance Specialist - 20 Years of Experience
Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....
Tags for this Online Resume: Data Analysis, Medical, Complaints, Quality, Risk Analysis
Industrial Engineer - 15 Years of Experience - Near 06422
SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...
Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,
Quality Engineer - 13 Years of Experience - Near 92630
I enjoy working with start-up or multi national/ global medical device companies. Apply my experience in mechanical engineering to design & development, remediation projects for class II medical devices.
Tags for this Online Resume: Product Development, Manufacturing, Medical Devices, Product Design, Training, Documentation, Packaging, Test, "project management", production, mechanical engineer, Project Engineer, USFDA 21 CFR (QSR), ISO 13485 (QSR), ISO 14971 (Risk Mngt), MDD/93/42/EEC, QA Engineering, Contract Eng. Start-up & Multi National/Global
Mechanical Engineer
Summary: * Results-driven Manufacturing & Product Engineering Professional with a strong background in process development and validation, technology, product transfers, fixture design, development, and validation within highly regulated medical device environments including optical, opto-mechanical, and electro-mechanical systems and devices. * 10+ Years' Experience in writing validation/verification protocols and reports,...
Tags for this Online Resume: Manufacturing, Documentation, Purchasing, Test, Critical Care - Vascular, ISO, ISO 9000, LAPAROSCOPY, Product Development, Urology
Data Mining Specialist - 20 Years of Experience - Near 30083
AREAS OF EXPERTISE * Data processing/Data tabulation * Confirmit (Survey Programming) * Qualtrics (Programming) * Dimensions (Tabulations) * SPSS/SQL * Quantum (Tabulations) * Extensive experience in data preparation and preparing for meaningful analysis * Highly qualified in data consistency * Strong knowledge of Word/ Excel * Excellent communication skills * Ability to manage multiple projects at once * Extremely creative...
Tags for this Online Resume: Documentation, Adobe Dimensions, Coding, Data Management, Management, Microsoft PowerPoint, PDF, Programming, Quality Assurance, Spss (Math/Stats Pkg)
Technical Writer
Tags for this Online Resume: Adobe FrameMaker, ArborText, Cms, Data Management, Documentation, English Language, Extensible Markup Language (XML), German Language, HyperText Markup Language, ISO
Clinical Regulatory Affairs - 20 Years of Experience - Near 80023
SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...
Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp
