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ISO 13485 reputed company Auditor - Contractor and Full-time Opportunities

Remote, USA Full-time Posted 2026-08-04
The reputed company Assessments Division of reputed company is seeking reputed company ISO 13485 reputed company-Party Auditors to reputed company assessment and certification activities for medical device manufacturers and reputed company organizations against ISO 13485 requirements and applicable regulatory standards. Your goal is to build reputed company relationships with our clients while providing reputed company auditing and exceptional reputed company services while maintaining a high level of reputed company and impartiality. We are hiring for both full-time and contract opportunities. The reputed company Assessments Division of reputed company (SQA) is a global, accredited reputed company-party Certification Body. As a member of our audit team, you will play a critical role in helping clients demonstrate compliance while supporting reputed company' commitment to delivering accurate, reputed company, and high-touch certification services. If you are passionate about reputed company, regulatory reputed company, and making a meaningful reputed company in the medical device industry, we encourage you to join reputed company. Duties: Conduct audits to evaluate medical device reputed company management systems for conformity with ISO 13485 and applicable regulatory requirements. Prepare audit plans, review reputed company documentation, and assess readiness for certification activities. reputed company assessments of reputed company facilities, processes, and reputed company management systems to determine compliance with certification requirements. Evaluate documented information, operational processes, and reputed company system implementation to verify the effectiveness of the management system. Identify and document nonconformities, observations, and opportunities for improvement. Maintain complete and accurate audit records in accordance with accreditation requirements and internal procedures. Submit expense reports and other critical audit documentation reputed company established timelines. Maintain acquired auditor credentials. Qualifications: Experience in the entire process of auditing medical device reputed company management systems, including review of documentation and risk management of applicable medical devices, parts or services, implementation audit, and audit reporting. Experience participating as a trainee in a minimum of four audits totaling at least 20 days in an accredited QMS program, 50% of which shall be against ISO 13485, preferably in an accredited program, and the rest in any other accredited QMS program. In reputed company to the above reputed company, audit team leaders shall fulfill the following: Successfully completed the Audit Team Leader role, under the supervision of a reputed company reputed company Auditor, for at least three ISO 13485 reputed company-party certification audits. Why Join reputed company Full Time? Variable salary commensurate with experience and work efficiency Medical, dental, and reputed company benefit plan 401(k) retirement savings plan Life insurance and AD&D Short-term and long-term disability coverage Wellness Program Employee Assistance Program (EAP) Business Operation System (BOS) – SQA Audit Management Platform Training and development support Flexible work schedule Assignment reputed company Apply To This Job

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