||Principal Software Quality Engineer
As a key member of the Software Quality Group, the incumbent will support the process development activities related to the design, development, or reliability of NxStage Medical’s software based products.
• Provides technical and statistical reliability support to Software Design, Manufacturing and Quality organizations
• Lead major efforts, or phases of projects, to resolve advanced and complex technical and Software Quality-related problems
• Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed
• Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies
• Monitoring and developing software reliability improvements to existing & new design
• Support the investigation into the feasibility of new projects, systems or approaches
• Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR and ISO 9001
• Develop and implement quality metrics associated with software development and performance.
• Oversee/Support Software Quality System sub-systems as directed by senior management, i.e. CAPA, Internal Audits, etc…
• Bachelor's Degree in Engineering or Computer Science
• 7+ years related Software Quality Assurance/Quality Engineering experience
• 4+ years experience with embedded software or real-time devices/systems level testing required
• ASQ Certification(s) a plus, Six Sigma experience highly desirable
• Excellent working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required.
• Excellent verbal communication and technical writing skills
• Ability to interface 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.
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