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Job Title: 

Software Qualiy Engineer

Job ID: 

mrsa1180

Location: 

Denver, CO

Industry: 

Medical Device

Job Type: 

Full time

Description: 
Software Quality Engineer

Responsibilities: 
Responsible for ensuring that the software used as part of our medical devices and products is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation. Translate quality standards into processes and procedures and apply these to the design process.

Requirements: 
Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering 3+ years in a software quality engineering or software test role dealing with software that is part of a medical device, or a product for a highly regulated industry i.e. aerospace, automotive, etc. Working knowledge of product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle Understanding of current Software Quality techniques and software industry standards (e.g. ISO, IEEE, CMMI), and their impact on internal procedures, software quality, safety and efficacy of products Working knowledge of C, C++, and LabVIEW Understanding of the FDA Quality System Regulation, ISO 13485, and Medical Device Directive a plus, not required

MUST BE AUTHORIZED TO WORK IN THE US, SPONSORSHIP AND TRANSFER OF H-1B VISA NOT AVAILABLE.

Education: 
BS in Electrical Engineering, Computer Science, or Computer Engineering

Compensation: 
$77,500 to $105,000 + 5% bonus Relocation provided

Contact: 

Management Recruiters of Santa Ana Inc.
17853 Santiago Blvd # 107-168
Villa Park, CA 92861
Tel: (714) 565-0010 Ext: 110
Fax: (714) 565-0020
resume@socalmri.com