• Randolph , MA
  • Information Technology
  • Full-Time
  • 640 N Main St

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Position Specific Details

NxStage Medical, a Fresenius Company is on a mission totransform renal care. To do that, we continually seek the best-of-the-best toexpand and improve our team of dedicated, innovative professionals. If youshare our mission and are committed to improving the lives of renal patients,then we invite you to explore our career opportunities.

Position Summary:

As a key member of theSoftware Quality Group, the incumbent will support the process development activities related to thedesign, development, or reliability of NxStage Medical s software-basedproducts.

Core Responsibilities:

Provides technical and statistical reliability support to SoftwareDesign, Manufacturing and Quality organizations

Lead major efforts, or phases of projects, to resolve SoftwareQuality-related problems

Lead/support Risk Management activities to ensure software design andprocess shortcomings are identified and appropriately addressed

Support the product development teams in the adoption and use of bestpractices, Quality tools, and Software Design Control methodologies

Develop and execute systems level and functional area tests

Monitoring and developing software reliability improvements to existing& new design

Strong analytical and problem-solving skills, ability to multitask inan environment with changing priorities

Investigate/reproduce customer problems/issues

Work with other Groups to maintain an approved internal Quality Systemthat meets the requirements of GMP s, QSR and ISO 9001

Develop and implement quality metrics associated with softwaredevelopment and performance.

Support Software Quality System sub-systems as directed by seniormanagement, i.e. CAPA, Internal Audits, etc



  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Requirements:

    Bachelor's Degreein Engineering or Computer Science

    7+ years relatedSoftware Quality Assurance/Quality Engineering experience

    4+ years experience with embedded software or real-time devices/systemslevel testing required

    ASQCertification(s) a plus, Six Sigma experience highly desirable

    Working knowledgeof FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required.

    Excellent verbalcommunication and technical writing skills

    Ability tointerface with multiple groups in the organization.

    Experience with structured programming languages and scripting desired

    Software - Computer skills C++, C, Java and object oriented design,embedded software design and automated testing, data security.


    :Information Technology

    Primary Location

    :United States-Massachusetts-Lawrence




    :Day Job::-
    Associated topics: performance test, prevent, qa, quality assurance analyst, quality assurance engineer, quality assurance lead, software quality, software quality assurance, software quality engineer, test

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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