Guerbet · 1 week ago

Senior Operations Quality Engineer

Raleigh, NC

Full-time

Onsite

Senior Level

10+ years exp

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Health CareMedical

Hiring Manager

Ndeye Coumba F.

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Responsibilities

Reviewing and approving site-related complaints, exceptions, and CAPA investigations in a compliant and timely manner.

Possessing technical knowledge with the ability to write or review technical documents.

Assisting in the completion of trending and metrics (i.e., Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis).

Completing department requirements for site Annual Product Quality Reviews (APQRs).

Performing investigations within each quality system when needed.

Assisting in Quality inspections from regulatory agencies, internal audits, and customer audits.

Providing final approval of site simplified and standard CAPA records.

Providing data to Site Management upon request for EXC, CAPA, DNC, and Complaint records.

Leading site Kaizens or brainstorming initiatives.

Acting as Quality Assurance oversight for project teams.

Qualification

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Quality AssuranceDocumentationTechnical WritingMS OfficeProblem-SolvingHard WorkingDetail-OrientedAdaptabilityOrganizedDependableDecision MakingCommunicationASQ Certified Inspector/Auditor