品質データアナリスト / Quality Data Analyst
Core
Improves availability, quality, and usability of QMS data across eQMS/SaaS platforms to support ISO 13485:2016 clause 8.4 data analysis, global reporting, and management review inputs. (via careerplan.io/jobs/89-00D-C8-E69-quality-data-analyst-at-dot-compliance)
Role type
Quality Data Analyst
Builds
Dashboards, quality metrics, trend reports, and visualized insights for QMS data analysis
Domain
Medical Device / Quality Management Systems (QMS)
Deliverable
dashboards & analysis
Required skills
Data analysis, data cleansing, data governance, SQL, BI tools, eQMS platforms, SaaS platforms, ISO 13485:2016, ISO 9001
Preferred skills
ETL concepts, data mapping, data warehouse concepts, database concepts, AI governance, system integration
Technologies
eQMS, SaaS, SQL, BI tools, APIs
Responsibilities
Collect, structure, cleanse, and analyze QMS data from eQMS/SaaS platforms; Develop dashboards and trend reports to support ISO 13485:2016 clause 8.4 activities; Support data inputs for management review, CAPA monitoring, and audit readiness; Collaborate with system owners and IT to define data requirements and improve data quality; Identify data integrity issues and propose corrective actions.
Seniority
Mid-level, hands-on IC
