Quality Specialist II, QS
Core
Monitor, investigate, and resolve quality events (NCRs, Deviations, Complaints, SCARs, CAPAs) in a regulated medical device and diagnostics manufacturing environment.
Role type
Quality Specialist II (regulated quality systems)
Builds
Quality system records, audit readiness, product disposition decisions
Domain
Medical device and diagnostics manufacturing
Deliverable
dashboards & analysis
Required skills
Quality event investigation, CAPA management, nonconforming material disposition, Device History Record review, risk assessment support, audit support, SOP review, data entry, statistical process control familiarity
Preferred skills
SAP usage, MasterControl usage, GMP/ISO-regulated system experience, diagnostics or medical device manufacturing background
Technologies
SAP, MasterControl, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Manage closure of NCRs, Deviations, Complaints, SCARs, and CAPAs; Determine disposition of nonconforming materials; Conduct basic failure analysis investigations; Review DHRs and manufacturing documentation; Generate quality metrics reports; Support internal and external audits; Participate in Gemba walkthroughs
Seniority
Mid-level, hands-on IC