SQAFYI - Software QA Resource - FYI

US: QA/RA Engineer - Software Validation

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Date: 07-Jun-2013

QA/RA Engineer - Software Validation

* Enable rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence. * Review/approve product and process change control documentation and specifications. * Create and/or review documents required for CE Technical files. * Work closely with cross-functional representatives to Identify and resolve production and quality system deficiencies * Participate in the improvement of the design and manufacturing process for existing and new products

* B.S. in Engineering or other 4 year Bachelor's Degree required * Strong engineering skills with working knowledge of software validation techniques, 2-5 years. * Problem-solving techniques including root cause analysis and cause and effect analysis. Statistical techniques and methods * Working knowledge of Microsoft office products (Word, Excel, Access, and Project) and Solid Edge. * Solid working knowledge of Quality System Regulations (21CFR Part 820, ISO13485, 21CFR Part 11) * Demonstrated experience working with one or more of the following: automated manufacturing equipment, control systems, automated laboratory equipment, laboratory data capture system, manufacturing execution systems, computers running laboratory, clinical or manufacturing database systems * Demonstrated experience leading teams or providing guidance on determining how to validate, and the extent of validation required, for appropriate computer systems used in the design and manufacturing of medical device classified product(s) * Excellent written and verbal communication skills * Ability to define problems, collect data, establish facts and draw conclusions * Ability to effectively present information in one-on-one and small group situations * Good interpersonal, analytical and organizational skills

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Thank you,
Team SQAFYI - Software QA Resource FYI

US: QA/RA Engineer - Software Validation