Note: The job is a remote job and is open to candidates in USA. SiPhox Health is a medical device startup developing a decentralized, home-use diagnostic platform combining blood collection hardware, a desktop analyzer, and cloud software. The Associate Quality Engineer will support design controls, software validation, supplier quality, risk management, post-market surveillance, and the development of the company’s quality management system for FDA clearance and ongoing compliance.
Responsibilities
- Help establish and maintain the Design History File (DHF) to fulfill strict FDA 21 CFR Part 820.30 requirements
- Maintain complete product-lifecycle Traceability Matrices linking user needs, design inputs, design outputs, and verification/validation results
- Track design changes and review technical drawings, specifications, and bills of materials (BOMs)
- Assist in establishing software lifecycle activities adhering to IEC 62304 for both analyzer firmware and cloud reporting software
- Participate in validating cloud-based data transfers, cybersecurity controls, and automated report generation systems
- Document automated or manual software test scripts and maintain software configuration records
- Execute purchasing controls under FDA 21 CFR 820.50 to qualify and monitor critical component suppliers and Contract Manufacturing Organizations (CMOs)
- Maintain the company's Approved Supplier List (ASL) by tracking quality certifications and evaluating supplier performance metrics
- Coordinate incoming material inspections, issue Supplier Corrective Action Requests (SCARs), and manage supply chain deviations to ensure business continuity
- Participate in cross-functional risk assessment sessions using ISO 14971 frameworks
- Assist in drafting and regularly updating Failure Mode and Effects Analyses (FMEAs) covering hardware mechanics, software bugs, use errors, and clinical data pipelines
- Establish the infrastructure for tracking post-market surveillance data, trending metrics, and field performance
- Manage the intake, investigation, and root-cause analysis of customer complaints
- Evaluate adverse events for regulatory reporting thresholds under Medical Device Reporting (MDR) guidelines (21 CFR Part 803)
- Support the development of procedures for corrections, removals, and field safety notices under 21 CFR Part 806 (Recalls)
- Draft and edit Standard Operating Procedures (SOPs) as the company scales its initial Quality Management System (QMS)
- Log and coordinate internal Corrective and Preventive Actions (CAPAs), deviations, and supplier non-conformances
Skills
- • Bachelor's degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, Supply Chain Engineering, or a related technical discipline
- • 1–3 years of experience in a regulated industry; internships or co-ops at medical device companies are highly valued
- • Foundational understanding of FDA 21 CFR Part 820, Part 803/806, and ISO 13485 standards
- • Comfortable switching context between physical supply chains, hardware assemblies, and software repositories
- • Strong technical writing skills and high precision with data management
- • Prior exposure to combination products or SaMD (Software as a Medical Device) regulatory pathways
- • Familiarity with electronic QMS (eQMS) platforms
Benefits
- Highly competitive salary and early-stage equity options.
- Full medical, dental, and vision insurance.
- Direct mentorship from industry-veteran regulatory and quality executives.
- A seat at the table to build a company's first FDA-cleared system from the ground up.
- Remote/hybrid flexibility.
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