Remote Associate Quality Engineer - SaMD & FDA Readiness

SiPhox Health; Burlington (MA); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Equity options

Medical, dental, vision insurance

Mentorship from regulatory/quality VPs

Job summary

SiPhox Health is seeking an Associate Quality Engineer to anchor QA, regulatory, and supplier quality workflows as we pursue our first FDA 510(k) clearance for a home-use diagnostic platform. In a US-based role with remote/hybrid options, you will help establish the DHF, maintain traceability, and support software/hardware validation under 21 CFR parts 820/803/806 and ISO 13485.

Collaborating with engineering, supply chain, and post-market teams, you will contribute to building foundational QMS

Qualifications

• 1–3 years of experience in a regulated industry; internships or co-ops valued.
• Foundational understanding of FDA 21 CFR Part 820, 803/806, and ISO 13485.
• Comfortable switching context between hardware, software, and supply chain contexts.
• Strong technical writing skills and data management precision.

Responsibilities

• Design Controls & DHF Support to fulfill FDA 21 CFR 820 requirements.
• Software Quality & Cloud Validation (SaMD) per IEC 62304; validate data transfers and reports.
• Supplier & Supply Chain Quality Management including SCARs and CMOs.
• Post-Market Surveillance (PMS) data tracking and MDR reporting considerations.
• Core QMS Support: SOPs, CAPAs, deviations, supplier non-conformances.

Skills

Technical writing

Data management

Cross-functional collaboration

Education

Bachelor's degree in Biomedical/Software/Mechanical/Supply Chain Engineering or related technical discipline

Tools

eQMS platforms

Job description

SiPhox Health is seeking an Associate Quality Engineer to anchor QA, regulatory, and supplier quality workflows as we pursue our first FDA 510(k) clearance for a home-use diagnostic platform. In a US-based role with remote/hybrid options, you will help establish the DHF, maintain traceability, and support software/hardware validation under 21 CFR parts 820/803/806 and ISO 13485.

Collaborating with engineering, supply chain, and post-market teams, you will contribute to building foundational QMS