Sr. Engineer, Quality - San Jose - Gener8

    Gener8
    Gener8 San Jose

    1 week ago

    Description

    Sr. Engineer, Quality

    Gener8 is seeking a Sr. Quality Engineer to provide senior-level leadership supporting design development transfer manufacture of medical devices specialized instrumentation Establishes maintains improves Quality System processes ensuring compliance FDA QSR ISO 13485 ISO 14971 customer requirements.

    • Quality System Ownership & Leadership:
    • Provide leadership development maintenance Quality System procedures work instructions forms.
    • Lead document creation review approval oversee ECO/ECN processes ensure compliant implementation.
    • Oversight subject matter expertise document control workflows including ECO routing controlled document lifecycle management template maintenance part shared Quality System model Gener8 does not maintain dedicated Document Control department responsibilities distributed across senior Quality personnel Act internal SME ECO workflow design template governance controlled structure consistent implementation Engineering Operations Drive continuous improvement ensure compliance evolving regulatory customer requirements Design Development Transfer Support design controls verification validation risk management traceability Partner define product process quality requirements Ensure DHF DMR documentation compliant complete audit-ready Supplier Manufacturing Assist supplier qualification monitoring re-evaluation CAPA / Nonconformance Post-Market Lead mentor high-risk investigations robust root cause corrective actions Perform trend analysis drive actions prevent recurrence Audit Regulatory Prepare QMS support auditor interviews Maintain inspection readiness assigned quality processes Customer Cross-Functional Interface Interface customers clarify expectations documentation Collaborate resolve activities Communicate risks system gaps opportunities Supervisory May technical mentorship Engineers partners Specialists No managerial unless assigned Education Bachelor's degree Engineering Life Science related technical field Professional certifications ASQ CQE CQA CMQ/OE preferred Experience Years open-source software SystemsLife Science Medical Device regulated manufacturing Environment Demonstrated leading documents traces regulations interfaces impact Supervisor executives complexity RegulationsRoadmapManagerInterfaces experiencespecific guest}

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