Medical Device Auditor

Job Summary:The Medical Device Auditor (ISO 13485 Certified Lead Auditor) is responsible for conducting quality management system (QMS) audits to ensure compliance with ISO 13485, regulatory requirements (such as MDR, FDA 21 CFR Part 820), and applicable internal standards. The role involves planning, executing, and reporting audits for medical device manufacturers, suppliers, and related service providers, ensuring continual improvement and regulatory readiness.Key Responsibilities:Plan, conduct, and lead internal, supplier, and third-party audits in accordance with ISO 13485 and applicable regulatory standards (e.g., MDR, IVDR, FDA QSR).Prepare comprehensive audit reports, identifying nonconformities and opportunities for improvement.Evaluate the effectiveness of corrective and preventive actions (CAPA) and follow up on audit findings.Support the organization’s quality and compliance objectives by ensuring adherence to Good Manufacturing Practices (GMP) and risk management (ISO 14971).Participate in certification, surveillance, and re-certification audits as required.Maintain up-to-date knowledge of relevant international standards, regulations, and quality system requirements.Train and mentor internal auditors and staff on quality and regulatory compliance.Liaise with regulatory bodies, notified bodies, and certification agencies as necessary.Assist in developing and improving audit programs, tools, and methodologies.Qualifications & Requirements:Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.Certified ISO 13485 Lead Auditor (by a recognized body such as IRCA, Exemplar Global, BSI, or TÜV).Minimum 7+ years of experience in auditing medical device QMS or related regulatory compliance roles.Strong understanding of ISO 13485, ISO 14971, MDR 2017/745, IVDR 2017/746, and FDA 21 CFR 820.Experience with risk-based auditing and CAPA verification.Excellent analytical, communication, and report-writing skills.Ability to travel domestically and internationally (as needed).Preferred Qualifications:Knowledge of other standards such as ISO 9001, ISO 14155, or MDSAP.Experience in notified body or certification audit environments.Exposure to product life-cycle management and regulatory submissions.