Senior Software Quality Engineer
InnoTech Staffing • Manchester, NH31d • Onsite
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Senior Software Quality Engineer - medical device
InnoTech Staffing•Manchester, NH
•Onsite
About The Position
InnoTECH Staffing is looking to hire a fulltime permanent Senior Software Quality Assurance Engineer to support the development of life-changing medical devices for a company located in the Manchester. NH area.
Requirements
- MS/BS in Engineering, Computer Science or related discipline with at least 5 years’ experience in an FDA regulated industry.
- Working knowledge of FDA QSMR’s, ISO62304 and GAMP5.
- Excellent organization, communication, and technical leadership skills.
- Proficiency with Microsoft office tools: Word, Excel, PowerPoint, & Visio.
- The ability to clearly write procedures that others can easily follow.
Nice To Haves
- Experience with requirements definition and management for regulatory compliance a plus.
Responsibilities
- Partner with Project Managers, System Engineers, Quality Systems Management & Information Technology to support the implementation of critical software tools.
- Lead requirement capture discussions to convert users’ needs into technical requirements.
- Develop system level test strategy, test specifications and test protocols.
- Hazards analysis, failure modes analysis and mitigation design.
- Support development / configuration of custom software tools.
- Support device development teams through delivery of modern, validated software tools.
- Use experience within software product development or software tool validation of medical devices to provide guidance and assistance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
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