Greiner · 2 days ago

Quality Engineer II

Monroe, NC

Full-time

Onsite

Mid Level

2+ years exp

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ManufacturingMedical

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Responsibilities

Develop, maintain and monitor quality processes to ensure compliance to ISO and FDA regulations.

Quality representation for the development of new products and processes including evaluation of technical drawings, test methodologies, and validation to ensure compliance

Lead non-conformance investigations along with other departments to identify root cause and assure nonconforming products dispositioned properly.

Presents findings of trend review or nonconformances to team and/or management staff

Author technical reports regarding nonconformance and complaint investigations as well as effectiveness reports for completed CAPA

Completion of risk assessment such as pFMEA to identify risks to product for determining the concession release of material through the Material Review Board

Assist in determining quality improvements by using relevant statistical method to testing methodologies and/or manufacturing processes and leading improvement projects for safety, quality, and productivity based on findings

Represent Quality in change control process, validation, and continuous improvement activities for the Production and Quality Control departments as assigned

Analysis of Quality trends and reporting on them for management review as well as escalation of identified trends

Create, review and approve fixture designs and prototypes

Monitor the effectiveness of employee training required in the inspection processes

Author SOPs, test procedures, validation protocols and reports

Author engineering studies using scientific principles

Performs tasks accurately and with great attention to detail

Other duties as assigned

Qualification

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Six sigmaLeanQuality managementStatisticsStatistical process controlAccess databaseExcelComplaint handling softwareMedical device regulationInternational standardsQA applicationsWord processingSpreadsheetsDatabasesTechnical drawingsCADSolidWorksProblem-solvingAnalyticalInterpersonalTeam playerIndependent