Medical Device Auditor
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Job Description
Contract Medical Device Auditor conducting third-party audits for ISO standards at SGS. Requires strong background in medical devices and relevant certifications.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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