Senior Software Quality Engineer - medical device
InnoTech Staffing
Job Description
Job Description
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.
How you will make an impact as a Senior Software Quality Engineer:- 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
To be successful in this role, you will need the following skills and experience:
- 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
- Experience with requirements definition and management for regulatory compliance a plus
Vacancy posted 14 days ago
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