Senior Software Quality Engineer
On-siteManchester, New Hampshire, United States
Job Summary
Partner with Project Managers, System Engineers, and Quality Systems Management to implement critical software tools. Lead requirement capture discussions to convert user needs into technical requirements, then develop system-level test strategies, specifications, and protocols. Conduct hazards analysis, failure modes analysis, and mitigation design while supporting the development and configuration of custom software tools. Deliver validated software tools to device development teams, providing guidance on product development and tool validation within FDA-regulated industries. Requires MS/BS in Engineering or Computer Science with five years of experience, proficiency in Microsoft Office tools, and working knowledge of FDA QSMR, ISO 62304, and GAMP5. Located in Manchester, NH, this senior-level role offers full-time employment with benefits and potential sponsorship.
Required Qualifications
- MS/BS in Engineering, Computer Science or related discipline
- at least 5 years' experience in an FDA regulated industry
- Working knowledge of FDA QSMR's
- Working knowledge of ISO62304
- Working knowledge of GAMP5
- Excellent organization skills
- Excellent communication skills
- Excellent technical leadership skills
- Proficiency with Microsoft office tools: Word, Excel, PowerPoint, & Visio
- The ability to clearly write procedures that others can easily follow
Desired Qualifications
- Experience with requirements definition and management for regulatory compliance
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