What are the responsibilities and job description for the Sr. QA Compliance Specialist position at Truvian Sciences?
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 Sr. QA Compliance Specialist (on-site Truvian HQ ) to help lead our next phase of growth. 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 :
Ensure design output and manufacturing documentation meet FDA, ISO 13485, and QMS requirements.
Develop and oversee Truvian’s Supplier Management Program, ensuring suppliers meet quality and compliance standards.
Provide QA oversight for software development life cycle (SDLC) deliverables—including risk assessments, design controls, and validation testing.
Ensure all quality projects and validations comply with cGMP, QSR, and ISO standards.
WHAT YOU’LL BRING
Education & Experience
Key Skills & Qualifications
Salary Range : $165,000 - $185,000
This range considers the wide range of factors that are 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
Salary : $165,000 - $185,000
