We are seeking qualified professionals to serve as Contract Medical Device Auditors, responsible for conducting third-party evaluations of quality management systems in the medical device industry. These roles involve assessing compliance with key regulatory frameworks such as ISO 13485, MDSAP, MDD, MDR, and EU requirements.
Audit Responsibilities
Auditors will carry out on-site and remote assessments following established certification protocols. You will gather and evaluate technical documentation and quality system records to determine conformity. Based on audit evidence, you will make informed decisions regarding certification eligibility and continuation.
Active participation in witness audits conducted by SGS or recognized accreditation bodies is required. Auditors must remain current with evolving regulatory expectations and maintain all necessary credentials and internal compliance standards throughout their engagement.
Qualifications
- Required: Certification to ISO 9001
- Preferred: Minimum of two years’ experience with non-active cardiovascular, vascular, and neurovascular implants
- Preferred: Two or more years working with non-active, non-implantable ophthalmologic devices
- Specialized knowledge of sterilization techniques including ethylene oxide (EtO), irradiation, and moist heat is highly valued
Technical Expertise
Proficiency in interpreting and applying ISO 13485, MDSAP, and EU regulatory standards is essential. Experience with Medical Device Directive (MDD) and Medical Device Regulation (MDR) compliance frameworks will support effective audit outcomes.
