Engineer, QA II
Core
Manage supplier quality compliance, track corrective actions, and ensure material disposition for a pharmaceutical/regulated industry.
Role type
Supplier Quality Engineer
Builds
Supplier qualification processes, quality agreements, and compliant supply chains
Domain
Pharmaceutical / Regulated Manufacturing
Required skills
Root cause analysis (DMAIC, A3), Supplier audit coordination, Material disposition, Supplier metrics analysis, Regulatory compliance documentation, System updates (S/4, ASL)
Preferred skills
Supplier quality management expertise, GMP knowledge
Technologies
S/4 system, ASL (Approved Supplier Lists), Office applications
Responsibilities
Open, notify, and track SCARs (Supply Corrective Actions) with suppliers; Manage material disposition for blocked, on hold, or quarantine items; Coordinate supplier audits and quality questionnaires; Update supplier metrics and present data to management; Maintain supplier qualification records and systems; Train contractors on quality standards and GMPs.