Quality Assurance Compliance Specialist (Onsite) - Temp to Hire
Truvian Sciences
This job is no longer accepting applications
See open jobs at Truvian Sciences.See open jobs similar to "Quality Assurance Compliance Specialist (Onsite) - Temp to Hire" General Catalyst.Legal, Quality Assurance
San Diego, CA, USA
USD 106k-122k / year
Posted on Feb 6, 2025
About Truvian
Truvian is revolutionizing blood testing by developing an automated benchtop diagnostic system that delivers lab-accurate results within 30 minutes for a comprehensive suite of health tests. Our goal is to make routine health testing accessible, affordable, and actionable in retail and clinical settings. We are seeking FDA clearance for our proprietary approach, which aims to empower individuals with their health information.
At Truvian, we foster a culture of innovation, collaboration, and discovery. We believe in the power of teamwork to transform healthcare and improve lives. Join us in our mission to disrupt the industry and drive meaningful change.
Job Summary
Truvian is seeking a Quality Assurance Compliance Specialist (Onsite) – Temp to Hire to support the effective deployment and compliance of the Quality Management System (QMS). This role will ensure that Truvian meets FDA Quality Management System Regulation, ISO 13485, and international regulatory standards while supporting product quality.
As a key member of the Quality Assurance/Regulatory Affairs (QA/RA) team, you will work cross-functionally with R&D and manufacturing teams, providing guidance on compliance matters, managing quality issues, and driving continuous improvement initiatives. This role reports directly to the Head of Quality Assurance/Regulatory Affairs.
Why You’ll Love This Role
Key Responsibilities
Qualifications & Experience
Supervisory Responsibilities
Salary Range
Equal Employment Opportunity
Truvian is committed to diversity and equal opportunity. We prohibit discrimination and harassment based on race, color, religion, gender, age, disability, national origin, veteran status, sexual orientation, gender identity, or any other legally protected status.
This policy applies to all aspects of employment, including hiring, promotion, compensation, and training.
Join us at Truvian and be part of a team dedicated to transforming blood testing and healthcare innovation!
Truvian is revolutionizing blood testing by developing an automated benchtop diagnostic system that delivers lab-accurate results within 30 minutes for a comprehensive suite of health tests. Our goal is to make routine health testing accessible, affordable, and actionable in retail and clinical settings. We are seeking FDA clearance for our proprietary approach, which aims to empower individuals with their health information.
At Truvian, we foster a culture of innovation, collaboration, and discovery. We believe in the power of teamwork to transform healthcare and improve lives. Join us in our mission to disrupt the industry and drive meaningful change.
Job Summary
Truvian is seeking a Quality Assurance Compliance Specialist (Onsite) – Temp to Hire to support the effective deployment and compliance of the Quality Management System (QMS). This role will ensure that Truvian meets FDA Quality Management System Regulation, ISO 13485, and international regulatory standards while supporting product quality.
As a key member of the Quality Assurance/Regulatory Affairs (QA/RA) team, you will work cross-functionally with R&D and manufacturing teams, providing guidance on compliance matters, managing quality issues, and driving continuous improvement initiatives. This role reports directly to the Head of Quality Assurance/Regulatory Affairs.
Why You’ll Love This Role
- You will play a vital role in ensuring compliance with FDA Quality Management System Regulation, ISO 13485, and international regulatory standards.
- You’ll work with a passionate and innovative team dedicated to transforming healthcare.
- You’ll contribute to the company’s growth and product launch while helping shape quality processes.
- You thrive in a fast-paced and dynamic environment, where you can drive improvements and implement new processes efficiently.
- Enjoy competitive benefits, including Medical/Dental/Vision, Paid Life Insurance, 401K, Paid Parental Leave, and Flexible PTO.
Key Responsibilities
- Quality Management System (QMS) Oversight: Ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Audit Leadership: Lead and participate in internal and external audits, including managing corrective and preventive actions (CAPA).
- Process Improvement: Identify, document, and improve processes and procedures related to the QMS.
- Compliance & Training: Train teams on quality processes and ensure company-wide adherence to regulatory standards.
- Risk Management: Analyze quality data, identify potential compliance risks, and implement corrective measures.
- Cross-functional Collaboration: Work closely with R&D, manufacturing, and senior management to integrate compliance and quality into all processes.
- Regulatory Documentation: Maintain design control, process control, and post-market processes to ensure full QMS compliance.
- Stakeholder Communication: Represent Truvian in quality-related discussions with external stakeholders, including suppliers and regulatory bodies.
Qualifications & Experience
- 5+ years of experience in Quality Assurance, specifically in IVD (In Vitro Diagnostics) or a regulated medical device environment.
- Bachelor’s degree in Engineering, Life Sciences, Software, or a related technical discipline (or equivalent experience).
- Strong knowledge of FDA 21 CFR 820, ISO 13485, and international regulatory requirements.
- Proven ability to lead audits, manage CAPAs, and drive compliance initiatives.
- Experience with Medical Device Single Audit Program (MDSAP) and IVD.
- Strong problem-solving and analytical skills with a solution-oriented mindset.
- Excellent interpersonal and communication skills to collaborate across teams and influence quality improvements.
Supervisory Responsibilities
- This role does not have direct supervisory responsibilities.
Salary Range
- $106,000 - $122,000
- Final compensation depends on experience, skills, qualifications, and internal equity.
- Ability to lift up to 25 lbs. frequently and 75 lbs. occasionally (with assistance).
- Regularly required to stand, walk, stoop, kneel, and reach.
- Ability to perform tasks requiring close vision, depth perception, and color vision.
Equal Employment Opportunity
Truvian is committed to diversity and equal opportunity. We prohibit discrimination and harassment based on race, color, religion, gender, age, disability, national origin, veteran status, sexual orientation, gender identity, or any other legally protected status.
This policy applies to all aspects of employment, including hiring, promotion, compensation, and training.
Join us at Truvian and be part of a team dedicated to transforming blood testing and healthcare innovation!
This job is no longer accepting applications
See open jobs at Truvian Sciences.See open jobs similar to "Quality Assurance Compliance Specialist (Onsite) - Temp to Hire" General Catalyst.