Quality Engineer II

Position Summary:

The incumbent applies software and/or systems engineering and quality assurance principles and techniques to the software and product development lifecycles. The position will also perform software and/or system testing for NxStage medical devices and other business software and/or systems that supports the Quality System.

 Apply Here

 

Responsibilities:

·         Work with internal groups in creating project documents, and performing verification and validation testing required in an FDA-regulated environment.

·         Assist project teams in assessing the required validation activities for software systems.

·         Develop and execute procedures and scripts meant to test the performance of the following software:

–        Software contained in NxStage commercially distributed products.

–        Software used in the manufacture and/or testing of NxStage products.

–        Software used in NxStage quality systems.

·         Participate in team reviews related to software validation

·         Perform device system and performance testing in the lab.

·         Develop intermediate level testing strategies and software risk analyses.

 

Education Qualifications:

·         B.S. in Computer Science or Engineering Related Field

·         3+ years related quality assurance, software quality engineering experience or an equivalent

 

Requirements

 

·         Combination of experience and education. Medical device experience preferred.

·         ASQ certification a plus.

·         Intermediate knowledge of FDA Quality System Regulation 21 CFR Part 820.

·         Good organizational, attention to detail and follow-through skills

·         Excellent verbal communication and customer interface skills.

·         Ability to interface with multiple groups in the organization.

·         Systems - Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.

·         Software - Computer skills – C++, C, object oriented design, embedded software design, web design, database design, SQL server and Access, automated testing, data security.

·         Willingness to contribute to other departments as necessary

 

NxStage is an Equal Opportunity Employer

 

The following represents some of the main responsibilities of the above position.  This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position.  NxSTAGE Medical, Inc. maintains the right to modify this list at any time.