Description
Job Title: Software Quality Assurance Engineer - Senior (Medical Device)Duration: 12months +.
Location: Chaska, MN
Job Description:
- Provides software quality engineering support to medical device software development teams
Creates Software Risk and Hazard Analysis documentation - Working knowledge of EN IEC 62304:2006, `Medical device software - Software life cycle processes` and US FDA Guidance, `General Principles of Software Validation`
- Must have a working knowledge of quality assurance methodologies
Develops quality assurance standards - Audits program software and methodologies for compliance to industry and company requirements
- Defines and tracks quality assurance metrics such as defect densities and open defect counts
Experience in test plan development and implementation; has written and maintained test automation
- some travel may be required (~25 %)
- Requires a bachelor's degree and at least 5 years of experience coding; advanced degree or certification desired
- Relies on experience and judgment to plan and accomplish goals
Q: What software systems will they be working in?
A: Systems: General working knowledge of document management and configuration management systems, Visual Studio (where code resides), Cockpit (requirements and risk/hazard assessment tool), GIT
Q: What type of coding?
A: No coding required; looking for a process QA background versus a testing background; needs to understand the testing process, but will not be performing this as a function Needs knowledge and experience of good practices in a medical device company, working on product development ASQ certified SW QE would be desirable
Q: they need to have knowledge or familiarity with any programming languages?
A: Languages used in the product: C++ C# scheme
Q: How closely will they be working with the software development teams?
A: Hands-on QA, giving guidance regarding medical device development requirements to development teams Able to assess, scope and provide own deliverables independently, based on existing program and code content
Q: Is the standard daily schedule 8-5PM, any flexibility?
A: Negotiable
For immediate consideration, please contact the recruiter or call.