Senior Supplier Quality Engineer

Stark Pharma

  • Bothell, WA
  • 4 days ago
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    Skills

    • Auditingunmatched
    • Biologyunmatched
    • Code of Federal Regulationsunmatched
    • Continuous Improvementunmatched
    • Corporate Complianceunmatched
    • Corrective Actionunmatched
    • Cross-Functionalunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • FDA (Food and Drug Administration)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Auditunmatched
    • Manufacturing/Industrial Processesunmatched
    • Medical Equipmentunmatched
    • Onboardingunmatched
    • Operational Supportunmatched
    • Organizational Skillsunmatched
    • Performance Metricsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Process Validationunmatched
    • Quality Engineeringunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Regulatory Complianceunmatched
    • Supply Chainunmatched
    • Vendor/Supplier Evaluationunmatched
    • Vendor/Supplier Managementunmatched

    Description

    Job Title: Senior Supplier Quality EngineerLocation: Bothell, WA (100% Onsite)Duration: 6+ Month ContractJob SummaryWe are seeking a Senior Supplier Quality Engineer to support supplier quality operations within a medical device manufacturing environment. This role will focus on driving supplier quality improvements, resolving non-conformance issues, and ensuring compliance with regulatory and quality standards across the supply chain. The ideal candidate will have strong experience in supplier quality engineering, supplier audits, and manufacturing process improvements within FDA-regulated medical device environments.Key ResponsibilitiesInvestigate, resolve, and prevent supplier-related non-conformances impacting manufacturing operationsDrive supplier corrective and preventive actions to improve product quality and process performanceSupport implementation of design and manufacturing process changes at supplier sitesConduct and document part qualification and process validation activitiesPartner cross-functionally with Engineering, Manufacturing, Supply Chain, and Quality teams to prevent supplier-driven shortages and quality issuesLead supplier quality system and process audits to ensure compliance with company and regulatory requirementsMonitor supplier performance metrics and identify opportunities for continuous improvementSupport evaluation, qualification, and onboarding of new suppliersParticipate in departmental meetings, training sessions, and continuous improvement initiativesRequired QualificationsBachelor's degree in Engineering, Life Sciences, or related technical fieldMinimum 5+ years of experience in Supplier Quality, Quality Engineering, or related roles within the medical device industryStrong knowledge of FDA 21 CFR Part 820 and ISO 13485:2016 requirementsExperience conducting supplier audits and managing supplier quality systemsStrong communication, documentation, and problem-solving skillsExcellent organizational skills and attention to detail#J-18808-Ljbffr

    Numbers & Facts

    LocationBothell, WA

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