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
