US-UT-Draper: Staff Quality Engineer
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please visit http://sqa.fyicenter.com
Staff Quality Engineer
Responsibilities: Provide Quality Engineering support to R&D by ensuring proper quality plans are in place, creating and validating test equipment and processes, performing material dispositions, and other support as required.
Participate in new product development by writing and executing test protocols, developing test methods, creating product performance requirements, and ensuring all testing to support design control and product introduction is completed as required.
Perform internal and external quality system assessments. Participate in ensuring all aspects of the quality system requirements are met. Work with purchasing to maintain partnerships with suppliers.
Requirements: *Multi-level position: Position title and level posted is preferred. However, we will consider hiring at the Principal Engineer level.
A minimum of seven years experience is required for the Staff Engineer level. A minimum of ten years work experience is required for the Principal Engineer level. Medical device industry experience is preferred. Validation and Verification experience is essential. Additionally, experience with plastic component materials, bonding and test method development is desired. Experience within a product development focused organization is also preferred.
A Bachelor's degree in sciences or engineering is required.
Detailed knowledge of quality practices within the medical device industry, FDA Quality System Requirements (QSR), ISO 13485, ISO 14971 and Total Quality Management (TQM) practices a plus.
Excellent organizational skills, strong statistical skills, independent thinking, and a high level of initiative are a must. The ability to work well independently and as a member of a team is essential for success.
Must have strong communication skills, both verbal and written.
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Team SQAFYI - Software QA Resource FYI