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 procedures and ISO 13485, MDSAP, MDD, and MDR requirements.

• Make informed decisions regarding the audit process and notify SGS when issues arise that are beyond the scope of the audit.

• Gather and assess sufficient information to provide a recommendation for certification.

• Evaluate clients’ medical device quality systems and technical documentation against ISO 13485 and other regulatory standards.

• Determine whether registration should be endorsed or allowed to proceed based on the evidence from the audit.

• Engage in witness audits conducted by SGS or accreditation bodies.

• Maintain all necessary audit credentials.

• Follow internal standards, policies, and procedures diligently.

• Travel by car and plane to conduct audits, including trips to Canada and Mexico.

• Be prepared to travel on weekends when necessary to fulfill scheduling requirements.

⛳️ Requirements

• Over 2 years of direct sterilization experience, mainly in EO and Gamma.

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

• At least 4 years of experience in medical devices under ISO 13485, MDSAP, MDD, and/or MDR-compliant quality management systems.

• Preferred experience with cardiovascular soft tissue implants (MDN1101) and/or general non-active non-implantable healthcare devices (MDN1214).

• Familiarity with ISO 14001, ISO 45001, and/or ISO 50001-based management systems is preferred.

• Auditor credentials for ISO 13485, MDSAP, MDD, and/or MDR are preferred.

• Experience with non-active cardiovascular, vascular, and neurovascular implants is preferred.

• Experience with non-active, non-implantable ophthalmologic devices is preferred.

• Expertise in sterilization methods such as ETO, irradiation, and moist heat is preferred.

• ISO 9001 qualification is preferred.

• Proficiency in English at the highest advanced level.

• Exceptional verbal, written, presentation, communication, and interpersonal skills.

• A proactive attitude combined with excellent organizational skills.

• Ability to respond effectively in high-pressure situations and make clear, well-founded conformity decisions during audits.

• Capability to multitask and manage several projects while ensuring timely delivery of results.

• Demonstrates integrity, tact, and character.

• Intermediate proficiency with MS Office Suite, including Word, Excel, and PowerPoint.

• Must be willing to travel up to 80% by car and plane.

• Ability to travel to Canada and Mexico is required.

• Weekend travel may be required.

🏝️ Benefits

• Opportunity to work remotely.

• Commitment to being an Equal Opportunity Employer.

• Provision of reasonable accommodations for qualified individuals with disabilities.