US-OH-Cincinnati: Validation QA Engineer

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Date: 15-May-2009

Validation QA Engineer

Principal Duties and Responsibilities 1. Assures that the site Validation systems comply with all applicable sections of 21CFR 820, including guidelines, and to other domestic and international requirements for Medical Devices, including ISO standards, Medical Device Directives and Corporate Quality guidance. 2. Create protocols & reports for performing Process Validation (IQ, OQ & PQ) for new product transition from Research and Development to manufacturing and production and for major product and process modifications. 3. Maintain quality system for the site validation process and develop and maintain site master validation schedule for validations and re-validations. 4. Implement a risk based system to maintain adequate validation documentation systems and perform equipment, process and software validations, and determine need and schedule for re-validations. . 5. Seek out and apply best quality assurance methods and practices in support of Validation objectives. 6. Coordinate and execute process validations due to new design releases from RoHs change requirements. 7. Evaluate effectiveness of site validation procedures and implement necessary modifications to eliminate system gaps 8. Performs special assignments as assigned by the Quality Manager.

Requirements:

Knowledge, Skills and Abilities Required 1. Bachelor’s Degree in Engineering discipline required, Electrical or Biomedical preferred. 2. Experience and knowledge in ISO-13485 Quality Standards preferred. 3. Experience in quality systems for FDA, GMP and Medical Device Directive requirements preferred. 4. Knowledge of Risk Management systems, risk analysis, FMEA, and ISO 14971. 5. Excellent writing and interpersonal skills required. 6. Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint) 7. ASQ Certification as a Quality Engineer preferred. 8. Ability and skill in training personnel in company policies, procedures, and work instructions. 9. Six Sigma Certification preferred.

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