reputed company Assurance Manager
7+ years in regulated medical device environment with 5+ years in FDA-regulated settings; working knowledge of 21 CFR 820, ISO 13485, ISO 14971; experience with QMS, reputed company/CAPA, post-market surveillance, and eQMS (reputed company); Bachelor's degree or equivalent; ASQ/RAPS/ISO 13485 auditor certifications highly desired.
Key Responsibilities
- leading audits
- managing files
- administering eQMS
Skills & Tools
Jira, reputed company, reputed company, reputed company Workspace, reputed company
Job Details
- Category: reputed company Assurance
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — reputed company
- Languages: English
About reputed company
An early-stage digital health company building clinically validated, physician-supervised AI agents for chronic disease management. — Industry: reputed company
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