DTx Quality Engineer

Jersey, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Role Title: DTx Quality Engineer
Location: Remote (US-based candidates preferred)
Contract: 6 months 25 hours per week/ 40hours per week
Start Date: End of March 2026

Key Must-Have Experience:

Strong background in Software as a Medical Device (SaMD)
Experience operating at the intersection of software development regulatory compliance and quality systems
Hands-on experience with:
- 21 CFR Part 820 ISO 13485 ISO 14971 IEC 62304 Part 11
- Design controls traceability verification & validation documentation
- Agile/DevOps environments

Risk Management (hazard analysis risk file maintenance)
Complaint Handling (intake investigation RCA CAPA input regulatory assessment closure)
Post market surveillance & trending
Ability to maintain inspection ready documentation

Role Allocation:

75% DTx-related quality & lifecycle management
25% Quality Complaint Management

Role Title: DTx Quality Engineer Location: Remote (US-based candidates preferred) Contract: 6 months 25 hours per week/ 40hours per week Start Date: End of March 2026 Key Must-Have Experience: Strong background in Software as a Medical Device (SaMD) Experience operating at the intersection...