Principal Device Quality Engineer
Job Summary
Serving as the global subject matter expert, the full-time Principal Device Quality Engineer will oversee compliance in the design control process within the Software Development Lifecycle (SDLC), guiding Agile development while ensuring safety and regulatory adherence for digital health solutions, including Software as a Medical Device (SaMD) and AI/ML technologies.
Key Responsibilities
- Act as the primary authority on global regulatory standards, providing SME guidance on compliance and quality management
- Lead the integration of modern technologies into the Quality Management System (QMS) and support comprehensive risk management activities
- Drive compliance from concept to commercialization, managing the Design History File (DHF) and representing the software QMS during audits
Required Qualifications
- Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field; a Master's degree is strongly preferred
- 10+ years of experience in quality engineering or product development within the medical device industry
- Certifications such as ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt are preferred
Complete Job Description
The complete job description is available to members. Premium membership includes:
Full access to 45,457 remote jobs from human-vetted companies, updated daily
Resume Builder - AI-powered tool to craft, enhance, and tailor your resume to a specific job
Twice-monthly live group coaching and the full Remote Career Center
20% member discount on Career Services
Backed by a 30-day money-back guarantee
Company Company Name
Headquarters Headquarters
Founded Founded
Website
BBB URL BBB URL
The company description is available to members. Go Premium for full access to every job and company profile in our remote jobs database, backed by a 30-day money-back guarantee.
