Contract Medical Device Auditor
SGSRemotely
sterilizationmdrmdsapiso 13485mddetoirradiationmoist heat
Job Description
📋 Description
- Perform third-party audits per SGS Certification procedures
- Audit ISO 13485, MDSAP, MDD, MDR requirements
- Assess evidence and provide certification recommendations
- Conduct client audits of medical device quality systems and technical data
- Participate in witness audits and maintain credentials
- Adhere to internal standards and procedures
🎯 Requirements
- Bachelor’s degree in Engineering/Bioscience/etc. AND minimum 4 years in medical devices under ISO
- Preferred: Auditor credentials for ISO 13485, MDSAP, MDD, MDR
- Experience with non-active implants and sterilization (ETO, irradiation, moist heat) is a plus
- Strong English, communication, and organizational skills
- Proactive, able to multitask and manage multiple audits
- MS Office proficiency (Word/Excel/PowerPoint)
🎁 Benefits