Quality Assurance Specialist 3

San Diego, CA

Full Time

Truvian

Mid Level

About Truvian
Truvian is a fast-paced, disruptive healthcare company at the intersection of diagnostics and consumer technology. We’re building a fully automated, benchtop diagnostic system that delivers lab-accurate results from a small blood sample in just 30 minutes. Designed for retail clinics and private practices, our platform is currently undergoing FDA review and aims to revolutionize routine blood testing by making it more accessible, affordable, and actionable.
At Truvian, our mission goes beyond the lab. We are committed to empowering individuals with timely health data and fostering a culture of innovation, collaboration, and discovery. Join us and help realize our vision of transforming routine health testing for today’s connected consumers.

Position Summary
Truvian is seeking a highly motivated and detail-oriented Quality Assurance (QA) Specialist III to support quality operations within our manufacturing and production environment. This individual will play a key role in maintaining Truvian’s high standards for product quality and compliance by performing incoming inspections, reviewing batch records, managing nonconformances, and supporting daily manufacturing activities.
The QA Specialist III will ensure that quality system procedures are effectively implemented and followed, in alignment with FDA QSR, ISO 13485, and other applicable standards. This is a hands-on role ideal for a quality professional with strong operational experience, an analytical mindset, and a passion for continuous improvement.
This position reports to the Head of Quality & Regulatory. This is a high-impact, hands-on role based at our corporate headquarters in San Diego, California.

Key Responsibilities

Perform and document incoming inspection of raw materials, components, and subassemblies based on specifications and sampling plans.
Review Device History Records (DHRs), batch records, and production documentation for accuracy, completeness, and compliance with regulatory and internal requirements.
Identify and escalate discrepancies or deviations; collaborate with Manufacturing and Engineering to ensure timely resolution.
Support line clearance, in-process inspection, and final release activities within the manufacturing environment.
Participate in root cause investigations and assist with nonconformance and CAPA processes.
Work closely with Supply Chain and Receiving to ensure the timely disposition of materials.
Maintain and organize QA records, logs, and inspection reports per quality system requirements.
Assist in audits, validations, and change control processes related to manufacturing or inspection procedures.
Support internal training and onboarding efforts related to quality procedures and best practices.
Promote a culture of compliance and continuous improvement across the organization.

Required Qualifications

Bachelor’s degree in a life science, engineering, or technical discipline preferred; equivalent experience considered.
Minimum of 5 years of experience in a Quality Assurance role in a regulated manufacturing environment, ideally within IVD, medical device, or diagnostics.
Demonstrated hands-on experience with incoming inspection, batch record review, and manufacturing quality support.
Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and related quality system standards.
Working understanding of inspection tools (e.g., calipers, micrometers), sampling plans, and measurement techniques.
Excellent attention to detail, documentation skills, and ability to recognize compliance risks.
Proficiency with Microsoft Office and electronic quality management systems (eQMS); experience with ERP systems is a plus.

Strong communication and collaboration skills across cross-functional teams (QA, Production, Engineering, Supply Chain)

What You’ll Love About Working Here
At Truvian, we’re more than just a diagnostics company — we’re a mission-driven team committed to transforming the way people access and experience blood testing. Here's what makes working with us truly special:

Impactful Mission: Join a passionate team revolutionizing point-of-care blood diagnostics and making a tangible difference in healthcare access.
High-Energy Environment: Thrive in a fast-paced, high-growth startup that values innovation, collaboration, and purpose.
Comprehensive Benefits Package, including:
- Medical, Dental, Vision, and Life Insurance
- Flexible Paid Time Off (PTO) and Paid Parental Leave
- 401(k) plan with generous company match
Wellness Perks:
- On-site gym and fitness classes
- Access to a farm-to-table café with a 30% employee discount
- Kombucha, cold brew, and healthy snacks are always on tap

Supervisory Role

Travel Requirements

May require up to 10% travel

FLSA

Exempt

Work Location

Onsite

Salary Range

$93,000 - $104,000
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 final candidate qualifications and experience. Placement within the compensation range is determined by level, band, internal equity, and relevant qualifications.

Physical Demands

Ability to lift and move up to 5 lbs.
Frequently standing and sitting for long periods.
Visual requirements include close, distance, color, peripheral, and depth perception.

Application Instructions
We want to hear your story! To apply, please submit your resume and a cover letter outlining your experience and what excites you about joining Truvian.

Equal Opportunity Employer
Truvian is an Equal Opportunity Employer. We are committed to building a diverse and inclusive team where everyone belongs and thrives. All employment decisions are made based on qualifications, merit, and business needs — never based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.

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Do you have at least 5 years of experience in a Quality Assurance role within a regulated manufacturing environment (e.g., IVD, medical device, diagnostics)?*

Have you personally performed incoming inspections of raw materials, components, or subassemblies in a production environment?*

Have you reviewed Device History Records (DHRs) or batch records as part of your quality responsibilities?*

Are you familiar with and have worked under FDA QSR (21 CFR Part 820) and/or ISO 13485 compliance standards?*

Have you supported manufacturing line activities (e.g., line clearance, in-process inspections, final release)?*

Are you proficient in using basic inspection tools (e.g., calipers, micrometers) and applying sampling plans?*

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At Truvian, giving individuals unprecedented access to information that shapes their health is the bold mission that drives us. If you're interested in being part of a team that is set to disrupt healthcare, explore our openings and apply.

Quality Assurance Specialist 3

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