Quality Assurance Auditor

Clario is seeking a Quality Assurance Auditor to support and elevate quality and compliance across our clinical services. In this fully remote role based in Costa Rica, you will lead audits and assessments of Clario’s procedures, systems, and data to ensure regulatory compliance and the highest standards of service delivery. You will collaborate closely with internal teams, vendors, and clients to support continuous improvement and maintain robust quality standards across the organizationWhat We OfferCompetitive compensationPrivate health insuranceEngaging employee programsFlexible work schedulesAttractive PTO planFlex workspaceKey ResponsibilitiesPerform 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), including:Medical Device Development/Change ControlSystem RequirementsTesting/Validation RecordsInstallation QualificationSystem Maintenance RecordsMigration Plans/Records/ReportsOther computer system validation records and processesSupport the Continuous Improvement program through internal meetings and issue management.Other Duties:Author QA/Regulatory SOPs as needed.Conduct annual QA/Regulatory training courses for staff.Provide consulting services to contracted external sources when required.Assist in system testing execution when outside of auditing scope.What We Look ForHigh 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 HaveExperience hosting client audits or regulatory inspection is preferred.Experience with GMP and medical device QA is preferred.Prior remote work experience is preferred.Knowledge of regulatory requirements: 21 CFR Part 11, 21 CFR 820.20, ISO 9001/13485, ICH E6.Certification in auditing, ISO standards, or GxP courses.Other SkillsStrong analytical, organizational, and leadership skills.Detail-oriented with the ability to write concisely and accurately.Competent computer skills for document management and reporting.Working ConditionsTravel: 10–15% internationally or domestically as requiredLifting: 0–25 lbsComputer work for extended periodsAt Clario, we are committed to developing safer and more effective medical therapies by delivering high‑quality endpoint data and analytics. Our global teams collaborate across borders and disciplines to support clinical trials that improve patient outcomes worldwide.Clario is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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