Quality Systems Auditor

Consultant, Quality Systems Auditor, Medical Devices

Summary 

Our client, a revolutionizing software medical device company, is seeking a highly skilled Quality Systems Auditor with expertise in regulatory compliance for medical devices, specifically software as a medical device. This role will focus on auditing quality management systems to ensure compliance with global medical device regulations and standards.

Requirements 

·      ISO 13485 and MDSAP regulatory requirements and audit processes

·      21 CFR Part 820 compliance and the transition to QMSR

·      Software as a Medical Device (SaMD) and general software-related regulations

Nice to Have

·      Cybersecurity standards and best practices (nice to have)

Terms & Start 

·      Remote

·      1 week audit

Pay rate: 137-161