US-OH-MENTOR: Quality Systems Validation Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 02-Jan-2008

Quality Systems Validation Engineer

Position Summary:

The primary purpose of this position is to conduct all Quality System activities related to design, implementation and ongoing maintenance of the site master validation program in an FDA regulated environment. This position will perform data analysis on process variability, specify suitable sample plans, organize sampling and testing, and approve protocols and reports. This position will work closely with the Manager, Quality Systems and the Facility Engineer, and will interface with third party finished product suppliers on their validation programs. Maintain and follow all safety standards. 1. Design Validation protocols, specify suitable sample plans, organize sampling and testing for validation trials, approve validation reports, and support ongoing maintenance of site validation program. 2. Perform data analyses on raw material and processed product, to improve QC specification and batch acceptance rates. 3. Work with third party suppliers to assure adequate validation programs and documentation. 4. Assure compliance with FDA requirements and ISO standards for validation. 5. Conduct investigations and CAPA activities as required in support of Quality Systems activities related to batch failures and non-conforming materials. 6. Support new product development validation activities, continuous improvement actions and site objectives. 7. Resolve short and long term quality issues with suppliers, both internal and external. 8. Support customer quality complaints and assist in resolution in accordance with customer needs and compliance standards. 9. Identifies the root cause of problems and recommends the appropriate corrective measures. 10. Other duties as assigned.

Requirements

Bachelors Degree in Engineering or Science related field strongly preferred. Prefer ASQ registered CQE. 3-5 years experience in manufacturing Quality role. Strong process validation experience in an FDA regulated environment. Strong knowledge of statistical techniques for data analysis and sampling. Knowledge of FDA regulations for drugs and/or Medical Devices. Knowledge of basic microbiological techniques, knowledge of ISO and other international systems and knowledge of Quality Systems Regulations desired. Exposure to hazards associated with a production environment. This includes production related noises, dust, chemicals, etc. Appropriate personal protective equipment (safety glasses, gloves, shoes, lab coats, etc.) provided as necessary. Must be able to walk, climb stairs, lift minimum of 40 pounds and must be able to view a computer screen and fine parts at a minimum distance of 36 inches.

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com