Job Summary

A global healthcare information technology company has a current position open for a Remote Senior Quality and Compliance Engineer.

Core Responsibilities Include:

• Becoming the in-house subject matter expert for Atlassian QMS tools
• Owning the training management system and increase its effectiveness day by day
• Easing the record generation process while increasing traceability

Skills and Requirements Include:

• Extensive experience Atlassian tools; Jira and Confluence
• Extensive experience with 21 CFR Part 820 regulations
• Experience in obtaining and maintaining ISO 13485 & MDSAP certifications
• Experience in IEC 62304 software lifecycle framework
• Experience with digital health and cutting-edge AI/ML SaMD products
• Experience with internal/external auditing and should hold internal auditor certification/qualifications