Quality Assurance Compliance Analyst

1 week ago

San Diego, California, United States Truvian Sciences Full time
Job DescriptionABOUT TRUVIAN SCIENCES
Truvian Sciences is a pioneering healthcare organization that is transforming the landscape of blood diagnostics. We are committed to developing an automated benchtop diagnostic system that delivers lab-quality results within 30 minutes for a wide range of health tests. Our innovative approach aims to make blood testing accessible and affordable, utilizing a small blood sample to provide rapid results in retail and clinical settings.

POSITION SUMMARY
We are currently seeking a Quality Assurance Compliance Specialist to play a crucial role in our evolving journey. This position will focus on the effective implementation and adherence to Truvian's Quality Management System (QMS), encompassing areas such as Design Control, Risk Management, CAPA, Non-Conformance Reports, Complaints, and Supplier Management to ensure the highest product quality standards. The specialist will ensure that our QMS aligns with FDA regulations, ISO 13485, and relevant international standards. A strong understanding of IVD regulations is essential to maintain compliance within our systems and documentation. Collaboration with cross-functional teams will be key to providing quality support and guidance throughout R&D and manufacturing processes, driving compliant issues to resolution and escalating to senior management when necessary.

KEY RESPONSIBILITIES
  • Champion the Quality Management System across the organization.
  • Lead the development, execution, and upkeep of our quality management system, focusing on industry best practices.
  • Ensure compliance with FDA 21 CFR 820 and ISO 13485 standards.
  • Conduct training and monitor adherence to quality protocols within the team.
  • Participate in internal and external audits, managing corrective and preventive actions.
  • Document and analyze processes and procedures related to the Quality Management System.
  • Report on critical quality data and trends to identify areas for improvement.
  • Work closely with senior management to identify and mitigate compliance risks.
  • Integrate compliance and quality considerations into business and product development processes.
  • Foster a culture of continuous improvement and accountability within the quality team.
  • Support the Head of QA/RA in overseeing audits, corrective actions, and training.
  • Conduct regular risk assessments to ensure proactive quality management.
  • Ensure timely review of quality documentation, including Design Control and Process Control.
  • Act as a change agent to drive process improvements through strategic influence.
  • Represent the organization in quality-related matters with external stakeholders.
  • Evaluate post-market processes to ensure full compliance with QMS.

QUALIFICATIONS
The ideal candidate will possess:
  • Extensive experience in implementing Quality Management Systems and ISO 13485.
  • A bachelor's degree in a technical, engineering, life sciences, or software discipline, or equivalent experience.
  • In-depth knowledge of FDA 21 CFR 820 and ISO 13485.
  • Strong interpersonal and communication skills, with the ability to engage effectively with technical personnel at various levels.
  • Excellent problem-solving and analytical skills, with a proactive approach to identifying and addressing issues.
  • A minimum of 5 years of quality experience in IVD, focusing on Quality Management System Regulation and ISO 13485.

COMPENSATION
The salary range for this position is between $106,000 and $122,000, considering factors such as experience, skills, knowledge, and education. Offers will be based on the final candidate's qualifications and experience.

PHYSICAL REQUIREMENTS
  • Regularly required to use hands for various tasks and communicate effectively.
  • Ability to lift and move items over 25 lbs. repeatedly, and occasionally up to 75 lbs. with assistance.
  • Frequent standing, walking, and other physical activities are required.
  • Specific vision abilities required include close vision and depth perception.

Truvian Sciences is an equal opportunity employer, committed to fostering a diverse and inclusive workplace.

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