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    Manufacturing Quality Engineer - Danbury, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Danbury, United States

    3 weeks ago

    Default job background
    Description
    Roles & Responsibilities:
    • Oversee CAPA, work with Manufacturing, Operations and Engineering to assist with containment, root cause analysis, corrective action, and preventive action. Conduct effectivity checks for CAPAs.
    • Return Material Authorizations, supports RMA requests from customers, tracks, and trends RMA data for Management Review, they will assist with RMA investigations as needed and provide feedback to the customer. As well as complaint handling.
    • Monitor and measure Key Performance Indicators (KPIs) and present findings during Management Review
    • Conduct training to internal procedures.
    • Non conformances and Material Review Board (MRB), disposition non conformances, disposition discrepancy material reports, manage MRB process as needed, tracks and trends nonconformance and MRB data.
    • Represent Quality in product development teams/projects. Work with various Engineering groups or QA Manager to develop and execute plans including quality plan, risk management, Process Failure Mode and Effects Analysis (PFMEA), control plans, production part approval process (PPAP), part qualification checklist (PQC)
    • Design verification and process validation (IQ, OQ, PQ)
    • Process capability (cpk). Understand statistics and how it impacts statistical control over process.
    • Lead Supplier Corrective Actions Requests (SCARs) - containment, root cause analysis, corrective action, and preventive action.
    • Ability to interpret Geometric Dimensioning and Tolerancing (GD&T)
    • Work as directed by manager.

    Education & Experience :

    • Bachelor's degree in an Engineering discipline.
    • Knowledge of ISO 9001, ISO 13485 and other recognized international quality system standards.
    • Read, analyze, and interpret technical procedures and regulations.
    • Write technical reports, business correspondence, technical procedures, as well as administrative procedures.
    • Interpret and inspect to GD&T
    • Present proposals, data, and issues to Arcmed personnel at all levels.
    • Independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
    • Represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts.
    • Provide solutions to difficult technical issues associated with specific projects.
    • Determine and develop technical solutions to a wide range of difficult problems.
    • Experience with Epicor a plus.
    • Microsoft: Word; Teams; Visio; OneNote, PowerPoint, Outlook
    • Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
    • Ability to work with general office equipment.
    • Ability to work with and understand databases a must and the ability to learn technical skills.
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