Quality Specialist II (Supplier Quality Review Analyst)
Core
Support periodic reviews of existing suppliers by collecting quality data, issuing questionnaires, compiling evidence, and providing review packs for decision-making.
Role type
Supplier Quality Review Analyst
Builds
Supplier review packs and score cards for internal Quality/Supplier Quality teams
Domain
Medical device / IVD / Diagnostics / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data handling and reporting, Process adherence, Technical writing, Analytical problem-solving, Quality management systems knowledge, ISO 13485 standards knowledge, Deviation investigation, CAPA, Change control, Root cause analysis
Preferred skills
Experience with TrackWise or Master Control, Experience in regulated operational environments
Technologies
TrackWise, Master Control
Responsibilities
Maintain supplier review schedule, Issue and follow up on supplier questionnaires, Collect and collate supplier quality data, Compile supplier review reports using approved templates, Highlight missing information, overdue responses, trends, or potential concerns, Submit completed review packs to site Quality teams, Maintain tracker for open, completed, and overdue reviews, Ensure review records are complete, accurate, and audit-ready
Seniority
Mid-level (3-4 years experience)