967 Software Test Engineer Biotech jobs in Sparks,NV

B.S.M.E. or similar engineering degree, or B.S. with Industrial Technology or Engineering coursework
At least three years' experience as a Quality or Manufacturing Engineer or similar role
Knowledge of ISO9000, ISO13485 and AS9100 quality management systems and related requirements
Minimum qualifications statements (implied) – (no paraphrase): ISO9001 Quality Management; ISO 13485 Medical Devices Quality Management; AS/EN 9100 Aerospace Quality Management Systems
Working knowledge of computer systems and data processing, familiarity with complex ERP systems
Knowledgeable concerning statistical process controls and measurements
Familiarity with Six Sigma and Lean practices desirable
Drafting skills using Solidworks and AutoCAD desirable
Knowledgeable concerning mechanical principles, machining practices
Able to communicate effectively both orally and in writing at all levels within the organization as well as with external customers and suppliers
Organized, manages time effectively and able to prioritize competing tasks
Performs effective problem-solving techniques and root cause analysis on customer returns
Track and promptly communicates to customers regarding returns
Generate a monthly Return Material Authorization (RMA) and Non-Conformance Report (NCR) summary
In conjunction with Manufacturing Engineers, executes Corrective Actions and Preventive Actions
Generates Process FMEAs, Control Plans, Capability Studies, and Gage R&Rs; when required
Works with Manufacturing Engineers to execute special process validations
Generate protocols and execute installation qualifications, operational qualifications and software validations
Request and execute requirements associated with a process change request
Programs and sets up a variety of inspection equipment
Determines priorities with the Director of Manufacturing Systems and Technologies on inspection and quality improvement projects
Stays informed concerning new inspection technology and equipment, and investigates their potential applications
Recommends incorporation of new technology for company applications where feasible and practical
Other duties as assigned
CGI, Inc. maintains strict adherence to ISO 9001 Quality Management; ISO 13485 Medical Devices Quality Management and AS/EN 9100 Aerospace Quality Management Systems