Quality Engineer III
Artech Information Systems LLC
Design Quality Engineer IIILocation: Maple Grove, MN 55311 Onsite Duration: 12+ Months Payrate: $50.00 - $54.58/HR. on W2Core ResponsibilitiesSupport and lead Design History File (DHF) Remediation activities for sustaining medical device products.Perform gap assessments, evidence collection, documentation updates, and design control remediation.Create/update: Design Inputs & OutputsProduct SpecificationsComponent SpecificationsEngineering Drawings/PrintsDesign Review DocumentationVerification & Validation (V&V) TraceabilityMaintain end-to-end traceability between: Design InputsDesign OutputsRisk ControlsVerificationValidationLead updates to DFMEA and Hazard Analysis documentation.Support audit/inspection readiness and regulatory compliance.Collaborate with R&D, Manufacturing, Regulatory Affairs (RA), Document Control, and Quality teams.Must-Have Skills3+ years of Medical Device Industry experience.Strong knowledge of Design Controls.Experience with: Design History Files (DHF)Design Inputs/OutputsProduct SpecificationsComponent SpecificationsEngineering Drawings/PrintsExperience maintaining: DFMEAHazard AnalysisRisk Management DocumentationUnderstanding of: Verification & Validation (V&V)Traceability MatricesFDA/ISO Medical Device Design Control Requirements
Vacancy posted 5 days ago
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