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Guerbet · 8 hours ago

Principal Operations Quality Engineer

Raleigh, NC

Full-time

Onsite

Lead/Staff

8+ years exp

Guerbet is a global leader in medical imaging, offering a portfolio of pharmaceuticals, medical devices, and AI solutions. The Principal Operations Quality Engineer will ensure compliance levels are maintained, lead audits, and oversee the quality assurance processes within the organization.

Health CareMedicalPharmaceutical

Responsibilities

Lead position in the site execution of external audits from regulatory agencies (i.e SME, Inspection Room Representative). Position will take a lead role in the formulation of inspection responses and commitment completion follow-up

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

Complete department requirements for site Annual Product Quality Reviews (APQRs). Must have the ability to assess shifts and trends, as well as associate CAPA response as it relates to data obtained

Ability to write, review and final approve site related complaints, exceptions, and CAPA RCA investigations within a timely manner. When needed, may also perform investigations within each of the compliance quality systems

Possess process technical knowledge and writing capabilities

Ability to lead site Kaizens or brainstorming initiatives

Ability to support site annual or non-routine GMP training

Primary designee for Quality Operations Manager in his/her absence

Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards)

Providing day to day supervision and oversight of Operations QEs

Performs other duties as assigned by management

Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately

Support various information requests from Corporate and other departments. Interact with corporate support groups to drive global continuous improvement validation and supplier management programs

Assist QA Compliance Manager with special assignments or projects as directed

Seek out and apply best quality assurance methods and practices in support of Quality objectives

Performs other duties as assigned by management

Qualification

Regulatory complianceQuality Management ReviewsCAPA investigationsASQ certificationAnalytical knowledgeMulti-taskingTechnical writingDocumentation skillsOrganizational skillsInterpersonal skills