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.
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.
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
PHYSICAL DEMANDS AND WORKING CONDITIONS:
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.
Primary Location:United States-Massachusetts-Lawrence
Loading some great jobs for you...