Quality Assurance Compliance Analyst

2 weeks ago


San Diego, California, United States Truvian Sciences Full time
Job Overview

ABOUT TRUVIAN SCIENCES
Truvian Sciences is at the forefront of transforming blood testing through innovative technology. We are dedicated to developing an automated benchtop diagnostic system that delivers lab-quality results in just 30 minutes for a wide range of health tests. Our mission is to make blood testing accessible and affordable, allowing individuals to receive crucial health information quickly and conveniently.

POSITION SUMMARY
We are seeking a Quality Assurance Compliance Specialist to enhance our Quality Management System (QMS) as we advance our operations. This role involves ensuring adherence to our QMS, which includes Design Control, Risk Management, CAPA, NCR, and Supplier Management, to maintain high product quality standards. The specialist will ensure compliance with FDA regulations, ISO 13485, and other relevant international standards. A thorough understanding of IVD regulations is essential to keep our documentation and systems compliant.

KEY RESPONSIBILITIES

  • Champion the Quality Management System and lead its development and implementation.
  • Ensure compliance with FDA 21 CFR 820 and ISO 13485 standards.
  • Conduct training and monitor compliance within the team.
  • Lead internal and external audits, managing corrective and preventive actions.
  • Document and analyze processes related to the Quality Management System.
  • Report on critical quality data to identify areas for improvement.
  • Collaborate with management to mitigate compliance risks.
  • Work with cross-functional teams to integrate quality considerations into all business processes.
  • Support the Head of QA/RA in overseeing audits and corrective actions.
  • Conduct regular risk assessments to ensure proactive quality management.

QUALIFICATIONS
The ideal candidate will possess:

  • Experience in implementing Quality Management Systems and ISO 13485.
  • A bachelor's degree in a relevant field or equivalent experience.
  • In-depth knowledge of FDA 21 CFR 820 and ISO 13485.
  • Strong communication skills to effectively engage with various levels of personnel.
  • Analytical skills to proactively identify and resolve issues.
  • A minimum of 5 years of experience in Quality Assurance within the IVD sector.

COMPENSATION
The salary range for this position is $106,000 - $122,000, reflecting factors such as experience, skills, and qualifications.

PHYSICAL REQUIREMENTS

  • Ability to perform tasks requiring manual dexterity.
  • Capacity to lift and move items weighing over 25 lbs. regularly.
  • Frequent standing, walking, and other physical activities.

Truvian Sciences is committed to providing equal employment opportunities and fostering a diverse workplace.



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