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Quality Engineer
Ref No.: 17-02428
Location: Springville, Utah
Job Title: Quality Assurance Engineer
Location: Springville, UT
Duration: 3 month contract
Pay range: $30-$36/hr DOE

Job Responsibilities:
Quality Assurance, Quality Management Systems, and Regulatory Compliance.
Advanced quality planning activities in Medical Device Contract Manufacturing environment including Risk Management, ORT, pFMEA, Supplier Selection and Qualification, Inspection Plans, and Control Plans supporting new product launches.
Lead business teams to address Corrective and Preventive Corrective Actions using brainstorming, 5-Why, Cause & Effect and other proven problem solving techniques to deliver problem solving methods to the factory products and processes.
Manage the site CAPA process including formal, effective and detailed reviews to assure the business makes progress in problem solving with verification of corrections and tracking of results.
Manage the site NCMR & MRB process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results.
Coordinate QMS alignment and improvement activities across locations to assure efficient and proper execution of compliance to ISO13485, ISO9001, ISO 14001, and USA FDA CFR part 820 cGMP.

Job Requirements:
BS in a technical / scientific discipline such as Mechanical, Electrical, Electronics, Manufacturing or similar technical degree, preferred
Clear understanding of the elements of ISO 13485 QMS processes, USA FDA part 820 regulations
Knowledge with Failure Analysis of Electrical Circuits and PCBA's.