ABOUT TRUVIAN

Are you ready to be part of a fast-moving, disruptive company revolutionizing blood testing? Truvian is a healthcare company at the cutting edge of diagnostics and consumer technology. We are developing an automated, benchtop diagnostic system designed to deliver lab-accurate results in just 30 minutes—from a small blood sample, in a retail or private clinic setting.

At Truvian, this is more than just a job—it’s a mission. We are a team of trailblazers committed to making health information accessible, affordable, and actionable for today’s consumers. If you thrive in a fast-paced, innovative environment and want to help redefine routine health testing, we’d love to hear from you!

ABOUT THE ROLE

Truvian is looking for a Senior / Staff QA Compliance Specialist (on-site Truvian HQ) to help lead our next growth phase. In this role, you will ensure that design outputs, manufacturing documentation, and supplier management programs align with Truvian’s Quality Management System (QMS), FDA Quality System Requirements, and ISO 13485/MDSAP standards.

This position will work closely with the Head of Quality Assurance & Regulatory Affairs and cross-functional teams to ensure compliance with our quality systems, from new product introduction (NPI) and supplier management to post-market sustaining activities.

You’ll play a pivotal role in shaping Truvian’s compliance strategy, leading internal audits, supplier oversight, and software quality assurance—all while ensuring that our processes stand up to FDA and notified body scrutiny.

📌 This role reports directly to the Head of Quality Assurance & Regulatory Affairs.

WHY YOU’LL LOVE THIS JOB

✔ Impactful Work – Your contributions will ensure Truvian’s Quality Management System remains compliant with FDA, ISO 13485, and international regulatory standards.

✔ Innovative Environment – Be part of a passionate, forward-thinking team dedicated to disrupting healthcare with cutting-edge diagnostic solutions.

✔ Leadership Opportunity – Play a key role in shaping quality systems, supplier management programs, and regulatory strategies while educating cross-functional teams.

✔ Fast-Paced & Agile – Work in a dynamic, startup-like environment where new ideas and efficient execution are valued.

✔ Great Benefits & Culture – Enjoy competitive compensation, generous benefits (Medical/Dental/Vision/EAP/Life Insurance/LTD/401K), paid parental leave, flexible PTO, and more!

WHAT YOU’LL DO

This role is responsible for ensuring the delivery of Truvian’s diagnostic products into diverse, global markets by maintaining compliance, supporting audits, and enhancing supplier and manufacturing processes.

Key Responsibilities:

• Quality System Compliance & Audits
  • Ensure design output and manufacturing documentation meet FDA, ISO 13485, and QMS requirements.
  • Lead internal audits, supplier audits, and corporate compliance audits—including FDA inspections and post-audit responses.
  • Serve as a QA Subject Matter Expert for risk management, requirements, protocols, and reports.
  • Support CAPA (Corrective and Preventive Actions), Non-Conforming Materials (NCMR), and Material Review Board (MRB) activities.
• Supplier Management & Manufacturing Compliance
  • Develop and oversee Truvian’s Supplier Management Program, ensuring suppliers meet quality and compliance standards.
  • Establish supplier partnerships, monitoring quality, materials, and product specifications.
  • Conduct supplier qualification and audits, ensuring adherence to regulatory standards.
• New Product Introduction (NPI) & Software Compliance
  • Provide QA oversight for software development life cycle (SDLC) deliverables—including risk assessments, design controls, and validation testing.
  • Guide post-market software design changes, CAPAs, and sustaining activities.
  • Evaluate evolving regulations and digital health initiatives for potential integration into Truvian’s QMS.
• Regulatory & Continuous Improvement
  • Ensure all quality projects and validations comply with cGMP, QSR, and ISO standards.
  • Identify opportunities for process improvements and risk mitigation within the QMS.
  • Collaborate with cross-functional teams to enhance design control, traceability, and documentation processes.

WHAT YOU’LL BRING

🎓 Education & Experience

• BA/BS in Engineering, Life Sciences, Software, or a related technical field.
• 8+ years of Quality Assurance experience in medical devices, IVD, or biotech industries.
• Strong expertise in Design Controls, Supplier Management, QMS, and Software Quality.

✅ Key Skills & Qualifications

• Expert knowledge of FDA, ISO 13485, MDSAP, MDR, and global regulatory standards.
• Experience leading FDA inspections notified body audits, and corporate audits.
• Strong understanding of Design Controls, Risk Management, and Software Quality Engineering.
• Ability to implement Supplier Management Programs—including audits and qualification processes.
• Proficiency in QMS tools, ERP systems, and Microsoft Office Suite.
• Excellent problem-solving, analytical, and project management skills.

💰 Salary Range:

• $165,000 - $185,000 – Staff Level
• $148,000 - $125,000 – Senior Level

This range considers the factors considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.

ADDITIONAL DETAILS

📌 Supervisory Role: No
📌 Travel Requirement: Some travel may be required
📌 Physical Demands: Prolonged periods of sitting and working on a computer

READY TO JOIN US?

If you’re excited about this opportunity, we’d love to hear from you! To stand out, please include a cover letter outlining your experience and why you're passionate about this role.

At Truvian, we celebrate diversity, innovation, and teamwork. We are proud to be an equal opportunity employer, committed to fostering an inclusive environment for all employees.

#JoinTheRevolution #QualityExcellence #TruvianDiagnostics