Medical Device Auditor

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct third-party audits in accordance with SGS Certification protocols and requirements for ISO 13485, MDSAP, MDD, and MDR.

• Make informed decisions related to the audit process and communicate with SGS to address issues that arise outside of the audit framework.

• Gather and assess adequate data to formulate a recommendation for certification.

• Execute audits for clients' medical device quality management systems and technical documentation.

• Determine if registration should be endorsed or allowed to proceed based on audit findings.

• Actively engage in witness audits conducted by SGS or accrediting organizations.

• Maintain all necessary audit credentials.

• Comply with internal standards, policies, and procedures.

• Travel up to 80% via automobile and airplane, including potential weekend travel.

⛳️ Requirements

• Bachelor’s degree in a relevant field such as Engineering, Bioscience, Biomedical, or Science.

• A minimum of 4 years of experience in the medical device sector, specifically with ISO 13485, MDSAP, MDD, and/or MDR-compliant quality management systems.

• Over 2 years of experience with non-active cardiovascular, vascular, and neurovascular implants.

• More than 2 years of experience with non-active, non-implantable ophthalmologic devices.

• At least 2 years of experience with general non-active, non-implantable healthcare devices.

• Expertise in sterilization methods, particularly EtO, irradiation, and moist heat.

• ISO 9001 certification.

• Proficiency in English at the highest advanced level; Spanish is a plus.

• Strong understanding of the technical applications of the relevant standards.

• Intermediate skills in MS Office Suite (Word, Excel, PowerPoint).

• Willingness to travel up to 80% by automobile and airplane, including possible weekend travel.

• Capability to make clear and well-founded conformity decisions during audits.

• Ability to multitask and handle multiple projects while ensuring timely delivery of results.

🏝️ Benefits

• Comprehensive health and wellness plans.

• Opportunities for professional development and growth.

• Flexible working arrangements.

• Competitive salary and performance incentives.