Global Medical Device Auditor | ISO 13485 & MDSAP

SGS North America Inc.; Lincolnshire (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

SGS North America Inc. is seeking a Contract Medical Device Auditor to perform third‑party audits of medical device quality systems and related technical information in compliance with ISO 13485 and applicable regulatory standards. The role involves making conformity decisions and providing certification recommendations to clients.

Travel up to 80% across the United States, Canada, and Mexico is required. Ideal candidates hold a related Bachelor’s degree with 4+ years of experience and possess

Qualifications

• Bachelor's degree in a related discipline and minimum 4 years of experience with medical devices under ISO 13485, MDSAP, MDD and/or MDR.
• Auditor credentials for ISO 13485, MDSAP, MDD or MDR are preferred.
• Experience with ISO 14001 / ISO 45001 / ISO 50001 and GMP quality systems is a plus.

Responsibilities

• Conduct third‑party audits of medical device quality systems and technical information to ISO 13485 and regulatory requirements.
• Decide on conformity and provide evidence-based certification recommendations.
• Participate in witness audits and maintain audit credentials.
• Travel up to 80% to client sites across the US, Canada, and Mexico.

Skills

English (Advanced)

Spanish (Preferred)

Education

Bachelor's degree in Engineering/Science

Job description

SGS North America Inc. is seeking a Contract Medical Device Auditor to perform third‑party audits of medical device quality systems and related technical information in compliance with ISO 13485 and applicable regulatory standards. The role involves making conformity decisions and providing certification recommendations to clients.

Travel up to 80% across the United States, Canada, and Mexico is required. Ideal candidates hold a related Bachelor’s degree with 4+ years of experience and possess