Perform third-party audits per SGS Certification procedures for ISO 13485, MDSAP, MDD and MDR
Collect and analyze sufficient information to provide a recommendation for certification
Decide upon evidence gained during audits whether or not registration should be recommended
Participate actively in witness audits by SGS or accreditation bodies
Maintain all audit credentials
Adhere to internal standards, policies, and procedures

Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.)
Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR
Knowledge of Non-active cardiovascular, vascular, and neurovascular implants
Knowledge of Non-active, non-implantable ophthalmologic devices
Knowledge of Sterilization experts (EtO, Irradiation, Moist Heat)
Knowledge of ISO 9001 qualification
Highest advanced level of English
Excellent communication and interpersonal, verbal, written and presentation skills
Proactive attitude and excellent organizational skills
Ability to multitask and manage multiple projects while delivering results on time

Medical Device Auditor

Key skills