Perform internal audits of Clario operational and technical departments to ensure compliance with SOPs, Good Clinical Practices (GCP), and ISO standards (9001/13485)
Conduct vendor audits to evaluate their Quality Management System and ability to meet Clario quality standards and contractual requirements
Assist in hosting and managing client audits and regulatory inspections
Analyze audit findings and collaborate with departments to generate effective Corrective and Preventive Actions (CAPAs)
Conduct follow-ups to ensure timely completion of CAPAs
Perform quality reviews of critical documentation related to Clario’s System Development Life Cycle (SDLC)
Support the Continuous Improvement program through internal meetings and issue management

High school diploma or associate degree required
Bachelor’s degree or equivalent in Health/Life Sciences, Clinical Sciences, or related field preferred
Minimum 1 year experience in Quality Assurance (QA) with a focus on Good Clinical Practices (GCP)
Strong self-management and organizational skills to work independently in a remote environment
Effective communication skills with internal and external stakeholders, including persistence in follow-up
Nice to Have: Experience hosting client audits or regulatory inspection is preferred
Nice to Have: Experience with GMP and medical device QA is preferred
Nice to Have: Prior remote work experience is preferred
Nice to Have: Knowledge of regulatory requirements: 21 CFR Part 11, 21 CFR 820.20, ISO 9001/13485, ICH E6
Nice to Have: Certification in auditing, ISO standards, or GxP courses

Quality Assurance Auditor

Key skills