Supplier Quality Engineering Specialist I (Onsite)

DescriptionCore Hours: Monday - Friday, 8am-5pmA higher level position may be considered depending on experiencePurpose and ScopeThe Supplier Quality Engineering Specialist I is primarily responsible for supporting supplier quality related processes including Contract Manufacturing/Packaging Organizations (CMOs/CPOs). This position also supports site inspection readiness activities.Essential Duties & ResponsibilitiesSupport the Supplier Change Notification Program, including completion of impact assessments.Own supplier-related quality events (deviations) and supplier corrective action reports (SCARs), including completing investigations and collaborating with technical subject matter experts and suppliers.Support the supplier complaint process as assigned.Support quality agreement program, including initiating and coordinating quality agreements with suppliers and other third parties.Support supplier audit program as assigned.Support supplier qualification and re-evaluation programs, including performing historical quality reviews, impact assessments, risk assessment and completing summary evaluations.Submit and monitor revisions to current department procedures.Assemble, review and submit supplier quality information to APQR team for annual reports.Perform supplier site visits to assist with supplier investigations as assigned.Support audit and inspection readiness activities, including providing training on associated processes/concepts to all levels of employees.Support post-audit and inspection activities (e.g. coordinating meetings, compiling data, etc.).Assist in preparing for and hosting external audits and inspections (FDA, Notified Body, Marketing Partners, etc.) including serving as a scribe, request taker or a

Created: 2025-12-05