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Online Resumes with "fda "



Sr. Medical Writing Coordinator

Document Specialist. Electronic FDA submissions

Tags for this Online Resume: Protocols, eCTD, Document Specialist, CSRs, FDA Submissions, publishing

Materials Scientist - 20 Years of Experience - Near 45011

Jonathan K. Mentzer 6964 Beagle Dr. Fairfield Twp, Ohio 45011 jmentzer6964@yahoo.com Home # 513-863-2974 The responsibilities at NEASE CO. LLC included resolving any quality issues that may occur. All instrument preventative maintenance and repairs are now the responsibility of the Quality Assurance and Quality Control (QA/QC) Supervisor. Writing, reviewing and training of procedures within the department to maintain C...

Quality Management Systems Professional

Combined 21 years of experience in Design, Manufacturing, Quality and leading global teams in achieving greater efficiency and productivity while meeting strategic and tactical goals. I bring a higher level of quality, integrity, and intensity of work while striving to achieve higher customer satisfaction. Seeking a senior management position in the Medical Device industry with a focus on quality assurance, process improvem...

Tags for this Online Resume: Greenwood, medical device, Quality, continuous improvement, auditor, Sr. level management, Quality Engineer, FDA, 13485

Configuration Management Professional - 20 years experience - Pittsburgh 15235

Detail-oriented, CMII certified configuration management professional offering versatile experience in master data, documentation and change control management utilizing industry standards and best practices. Extensive experience in FDA and ISO controlled environments. Comprehensive knowledge in the development of quality management system procedures, as well as quality audit and remediation process support. Proven team ...

Tags for this Online Resume: configuration management, Document Control, document, process, procedure, change, records, documentation

Compliance Manager - 4 Years of Experience - Near 08827

Qualification Summary-Operations Manager Global Regulatory Affairs and Operations: I possess a unique combination of well-developed marketing, sales, and training management skills with 4 plus years’ experience performing regulatory and operations management activities supervising all International Documentation and labeling statutory and regulatory requirements for the exportation of all Johnson & Johnson Consumer, Inc. c...

Tags for this Online Resume: FDA, Operations Manager, Regulatory Affairs, Telecommute, Export, Global, New Jersey

Mechanical Engineer - 20 Years of Experience - Near 60176

I have the ability to follow a project from Concept to Completion, either personally or in a TEAM environment. This consists of quoting, designing, ordering materials and components, fabricating & installing the equipment. Therefore, I feel that I can be an all around asset to any company. I was trained in and am very familiar with ISO 9000 Procedures along with LEAN manufacturing & Kaisen. I have extensive design experien...

Tags for this Online Resume: Automation, Solidworks, Inventor, Machinery, Engineer, Management, Autocad, Conveyor

Featured Profile

Quality Manager

I'm a Manufacturing Quality Manager with 25 years experience in pharmaceutical manufacturing, R&D, and validation. Expertise in seeing products through from R&D to market.

Tags for this Online Resume: Change Control, CAPA, Deviation, Audits, Quality, Validation, Management, Manufacturing, Packaging, SAP

Manager - 10 Years of Experience - Near 80022

Dedicated IT solutions architect knowledgeable in medical imaging departmental workflow, as well as imaging informatics, CT, and MR clinical application integration. Reliable project leader with dynamic problem solving abilities expertly applied to implementing systems and troubleshooting complex Tier 3 issues. Combine professional demeanor with collaborative and diplomatic communication strengths to liaise across multiple ...

Tags for this Online Resume: Customer Service, Help Desk, Windows, VMWare, Citrix, Training, Solutions, MSOffice

R&D Project Engineer

Tags for this Online Resume: medical device, design controls, implantable, solidworks, quality, orthopedics, product development, 13485, 14971, FDA

Experienced Quality Leader

Executive level professional that really enjoys the challenge of hands on problem solving. I enjoy building powerful teams across departments that focus on bringing out the best in each other and moving towards making things better and working smarter. I have years of experience in batch document review, investigating deviations, handling of regulatory interfaces such as inspections, leading and managing quality technical a...

Tags for this Online Resume: north Carolina, Continuous Improvement, Leader, Quality, Systems Builder, Emotional Intelligence

Technician - 20 Years of Experience - Near 08097

experience of 22 years in a FDA, CGMP regulated laboratory state of the art lab. I performed infectious disease testing and D.N.A.testing

Tags for this Online Resume: Philadelphia, cgmp enviornment, focused, reliable, independent worker, lab technician , research

Clinical Quality Assurance - 20 Years of Experience - Near 60090-2220

Reliable, dedicated professional with extensive experience in a wide range of areas within the pharmaceutical environment, including formulation, analytical lab testing, batch record review, documentation, clinical packaging, data review, auditing, CAPA, instrument calibration and training programs. Personable team player, conscientious, reliable, and flexible. Detail oriented, enjoy working with data and numbers and findin...

Tags for this Online Resume: GMP , SOP Revision, Training , Documentation, Calibration , Investigation