Engineer, Quality
Core
Ensuring supplier quality assurance and compliance for manufacturing sites through oversight of supplier lists, audits, and corrective actions.
Role type
Supplier Quality Engineer
Builds
Supplier qualification programs and quality compliance systems for manufacturing plants
Domain
Pharmaceutical manufacturing (API, Bulk Drug, Finished goods)
Deliverable
client delivery
Required skills
Supplier qualification, audit execution, CAPA management, statistical quality programs, SOP approval, impact analysis, regulatory compliance
Preferred skills
TrackWise, Veeva OneVault/OneTrack, SAP Enterprise, Excel, PowerPoint, Word, SharePoint
Responsibilities
Maintain approved supplier list and manage supplier qualification/performance; Conduct supplier audits and resolve supplier-related events; Perform product impact analyses and place materials on QA hold; Approve standard operating procedures for compliance; Participate in internal and external audits as subject matter expert; Develop and implement statistical quality programs for acceptance sampling.
Seniority
Mid-level, hands-on IC