Quality Assurance Compliance Specialist

About Truvian
Truvian is on a mission to revolutionize routine blood testing. We’re developing a benchtop diagnostic system that delivers lab-accurate results for a full suite of tests—in just 30 minutes—from a single small blood sample. Designed for use in retail clinics and healthcare settings, our proprietary platform, currently under FDA review, aims to make testing convenient, affordable, and actionable for everyone.

We are a passionate team of innovators committed to empowering individuals with better access to health information. If you’re excited to work in a fast-paced, mission-driven startup with the power to impact millions, Truvian is the place for you.

Position Summary
The Quality Assurance Compliance Specialist is responsible for ensuring Truvian’s Quality Management System (QMS) remains compliant with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and applicable international standards. This role will support cross-functional teams, oversee audits, and contribute to ongoing quality system improvements across R&D, manufacturing, and post-market activities.

You will be a key contributor in maintaining Truvian’s compliance posture as the company prepares for commercial launch and global expansion.

Key Responsibilities

• Champion the implementation, maintenance, and continuous improvement of Truvian’s QMS.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable international regulations.
• Provide quality and compliance guidance across R&D, operations, and manufacturing.
• Lead and participate in internal and external audits; manage CAPA and NCR processes.
• Analyze quality data and metrics to identify trends and areas for improvement.
• Conduct training on QMS procedures, best practices, and compliance expectations.
• Review and approve documentation related to Design Control, Risk Management, Complaints, and Supplier Management.
• Perform quality risk assessments and support post-market surveillance evaluations.
• Serve as a quality liaison with external regulatory agencies, suppliers, and customers.

• Bachelor’s degree in Engineering, Life Sciences, or related technical field (or equivalent experience).
• Minimum of 5 years of Quality Assurance experience in the in-vitro diagnostics (IVD) industry.
• Deep knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, and documentation skills.
• Excellent verbal and written communication skills.
• Experience scaling QMS processes in a startup or growth-stage environment is a plus.

• Experience with Arena QMS (preferred) or equivalent eQMS, especially in a document control–centered role.
• High attention to detail and excellent organizational skills.
• Proven ability to collaborate with cross-functional teams in quality, regulatory, engineering, and operations.
• Comfortable working in a fast-paced environment w