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Gondrecourt-le-Château

    Manufacturing Quality Engineer - St Paul, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences St Paul, United States

    1 week ago

    Default job background
    Description

    Responsibilities:

    Act as athe quality leader in the organization by participating as a member of the Material Review Board, supporting outside certification audits (eg ISO 9001:2015), advocating for a process-focused approach for all functions, and driving culture change from a reactive approach to a proactive approach Collaborate with the Det-Tronics Operations team to review and develop robust processes.

    This includes leading regularly scheduled quality meetings to evaluate and drive continuous improvement initiatives Review, report and analyze data to assess quality issue trends.

    Lead investigations and leverage root cause analysis methodologies, to assess quality issues and come up with corrective measures Provide leadership in Quality Audits of finished products, and testing units in a complete system setup.

    Provide reports of findings and assure corrective action has been taken Lead and facilitate production non-conforming materials control process, Material Review Board, to reduce major scrap and rejects Develop and implement programs to reduce scrap, improve the first pass yield metric and reduce the cost of poor quality Work closely with Engineering, Supply Chain, and Operations on all stages of Engineering change orders and production deviations.

    Work with a cross-functional team Improve data reporting or generate data reports Develops, modifies, applies, and maintains quality evaluation, control systems, and protocols.

    Analyzes and makes recommendations for corrective actions (CAPA) for nonconformities and/or design problems for internally produced products & processes.

    Utilizes PPAP core elements (e.g.e.g., PFMEA, MSA, Process Flow, Control Plans, etc.) to identify and make recommendations for managing risk in product development.

    Manages processes to ensure all requirements are met for work transfer and process change management including Resourcing Gate and Production Part Approval Process (PPAP) acceptance.

    Reviews process control documentation to ensure it is in compliance with requirements, objectives, and/or contracts.


    Other duties as assignedRequirements:

    Bachelor's Degree from an accredited college or university in Engineering or related technical field of study 2+ years of experience in a Quality Engineering role preferably in the manufacturing/industrial fields Quality certifications (e.g., QCT, CQPA) and/or Six Sigma certifications are preferred.

    Knowledge of ISO and IEC regulations and guidance (e.g., Design Controls, Risk Management, GxP) Must possess excellent analytical and organizational skills, and attention to detail, the ability to effectively communicate, drive and execute projects, and a strong aptitude for problem-solving Technical writing proficiency for creating, reviewing, and approving protocols/reports, work instructions, forms, and SOPs Advanced knowledge and experience in data analysis (CPK, statistical analysis), supplier quality metrics, non-conformance tracking, concurrent engineering, design for manufacturability, cost of poor quality, warranty, root cause analysis, and GD&T Knowledge of defining nonconformities, managing corrective actions, and identifying deficiencies in documents and process control Proficiency in JDE, SAP, Minitab, Excel & Power BI preferred Must have excellent written and verbal communication skills in English Language, and an open attitude for continuous improvement.

    Ability to perform under stress and meet project timelines, work cooperatively and respectfully with others, to lead others using project planning skills and documentation.

    Must be able to perform essential job functions safely and work within established company guidelines
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