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Validation Engineer Jobs
| Company | VivoSense |
| Address | , San Diego |
| Employment type | |
| Salary | $85,000 - $105,000 a year |
| Expires | 2023-09-22 |
| Posted at | 8 months ago |
VivoSense develops and validates real-world digital clinical measures and provides end-to-end services and solutions for their delivery in regulated clinical trials.
Validation Engineer
Remote - USA
About VivoSense:
Since 2010 VivoSense has been the premier science and technology company delivering end-to-end services and solutions for clients collecting clinical data from digital health technologies (DHTs), such as wearable sensors, mobile applications, and connected health monitoring tools. Working with drug developers, healthcare providers and academics, VivoSense develops and validates real-world digital clinical measures that matter to patients, and provides advanced software, analytics, and scientific expertise to improve the quality, accuracy, timeliness and ease of data analysis and insight generation from complex DHT data.
In 2022, VivoSense secured Series A financing and we are growing our team as we evolve our software platform, establish R&D capabilities and expand our client-facing business. We are seeking a talented and motivated individual to join our science team to bring expertise and the highest levels of quality to our client partnerships.
Responsibilities:
- Support the entire Software Development Life Cycle (SDLC) to ensure activities follow design control, software development, software testing comply with applicable procedures and standards.
- Support software defect tracking and monitoring with the development team.
- Executes software validation activities to include Change Control initiation, requirements/ protocol preparation, scheduling, protocol execution, data review and final report generation.
- Author validation protocols and reports for off-the-shelf software, configured software, and custom software.
Requirements:
- Experience working in a regulated Quality Management System, such as ISO 9000, ISO 13485, 21CFR820, 21 CFRPart11.
- Bachelor's degree in quality management, Life Sciences or Engineering Discipline with 3+ years of industry experience.
- Experience with GxP requirements.
Nice to have:
- Experience with Risk Analysis and Management.
- Experience with data privacy regulation HIPAA and GDPR.
- Experience working in a Cloud Based QMS, such as Verse, ETQ, MasterControl, or ComplianceQuest.
Salary Range: $85,000 - $105,000 (DOE)
Additional Benefits/Perks:
- Unlimited PTO
- Board approved stock options
- Board approved annual bonus
- Direct access to senior leadership
- Healthcare
- Vision/Dental
- Life Insurance
- Professional growth training
- 401K with Safeharbor employer contribution
- Remote work
- Flexible working hours
- Amazing culture and team to work with
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