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Online Resumes with "quality system regulations"



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

Accomplished New Product Development & Quality Assurance Manager

� Accomplished, self-starting New Product Development and Quality Assurance engineering manager � Over 10 years of experience in medical device development � Hands-on experience leading product development cycle from concept selection to commercialization in both New Product Development and Quality Assurance management roles, including voice of customer activities, concept selection, design characterization, verification an...

Ideal Companies: Johnson & Johnson, General Electric, Kimberly Clark

Tags for this Online Resume: Quality, New Product Development, Manager, Medical Device, Biomedical, NPD, Engineer, Research , QA, Development, Quality Assurance

Goal-oriented, meticulous, highly organized

not only exceptional technical competency but also superior analysis, problem-solving abilities, leadership, communication and team member experience.

Ideal Companies: Companies that have more than 50 employees and been in business for awhile.

Tags for this Online Resume: sales and marketing, customer service, regulatory affair, research and development, management, sales, development

Featured Profile

Senior Director, Chicago

To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry

Tags for this Online Resume: regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing

Regulatory Affairs Associate, New Jersey

Regulatory Affairs professional with a strong regulatory and compliance foundation, well-versed in the laws, regulations and requirements of the FDA; over six years of experience as an International Coordinator for a pharmaceutical organization, currently completing a graduate degree in Regulatory Affairs in Drug Development, Biologics and Medical Devices, studying all facets of regulatory requirements including processes a...

Quality Assurance Professional, Tampa

Motivated, personable business professional with 10 years of experience in Quality within the medical device industry. Accustomed to handling compliance and quality support for FDA, ISO13485, MDD, CMDR and JPAL products. Accomplished in Quality System Regulation implementation and improvement activities, auditing, CAPA investigations, root cause analysis, customer complaints, validations and process improvements. Demonstrat...

Tags for this Online Resume: quality, engineer, quality assurance, biology

manager

Over twenty (20) years of experience in the manufacture and packaging of pharmaceutical solid and semi-solid dosage forms. Results-oriented achiever with managerial experience in start ups at pharmaceutical facilities, validation processes and product launches. Goal- oriented individual with strong leadership capabilities. Organized highly motivated, and detail- directed problem solver. Depth knowledge in current and ne...

Tags for this Online Resume: DOE, trackwise, Product Transfer, microsoft , c'GMP, Lean Manufacturing

Production Supervisor -- 14 years experience

These sentences are to express my interest in the Production Supervisor position based on my skills in administration, leadership, communication, technical, development, performance management, statistical and computer knowledge, and problem solving. I am confident that I would be a great addition to your team. My resume that highlights my knowledge in manufacturing environment is enclosed on medical industry mainly....

Tags for this Online Resume: Production Supervisor

Quality Assurance Manager 12 years Experience

Quality Assurance experience in quality systems and system test. Quality systems background in areas of Continuous Improvement, ISO 9001/9002, ISO 13485, Quality System Regulation.

Tags for this Online Resume: ISO13485, GMP, CAPA, MRB, Product Release, Final Test

Featured Profile

Senior staff scientist / Program Manager

Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance

Ideal Companies: medical device companies; adjunct college professor; education manager within a company

Tags for this Online Resume: Product Quality Support, Product stability , medical device software validation, adjunct professor_biology

Clinical Research Associate

To obtain a Clinical Research Position in the Minnesota Area.

Tags for this Online Resume: Knowledge of 21 CFR, Quality System Regulation (QSR), Medical Device Reporting, Regulatory Compliance , Regulatory Submissions , ICH GCP Guidelines