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Lead Auditor – Contractor Role
Location
United States
Posted
66 days ago
Salary
Not specified
Job Description
Job Requirements
- Bachelor’s degree in:
- software engineering
- computer science
- physics or biophysics
- biology or microbiology
- chemistry or biochemistry
- electrical, electronic, mechanical engineering or bioengineering
- human physiology
- medicine
- pharmacy
- Minimum 4 years of experience in the medical device industry
- Minimum 2 years of experience auditing or managing QMSs under:
- ISO 13485
- EU MDR and/or UK MDR
- Preferred: Practical experience working with software.
- Prior work with notified bodies or accreditation bodies as a Lead Auditor
- Experience with software medical devices (SaMD) is strongly preferred
- Working knowledge of relevant standards, such as:
- ISO 14971
- IEC 62304
- IEC 82304
- Cybersecurity
Benefits
- Fully remote
- Flexible scheduling, subject to audit demand and availability
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