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    Quality Engineer - New York, United States - Novozen Healthcare LLC

    Novozen Healthcare LLC
    Novozen Healthcare LLC New York, United States

    2 weeks ago

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    Description
    Title – Quality Engineer
    Location – North Haven, CT (Onsite)


    MEDICAL DEVICE MANUFACTURING

    • Contribute to continuous improvements in overall product cost and quality.
    • Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.
    • Collaborate with Quality Engineering to provide manufacturing support.
    • Create standardized work and process maps that result in an optimized production system and extended value stream.
    • Support line validation / qualification activities for including IQ, OQ , MSA and PQ.
    • Perform root Cause Analysis (RCA), NCR and CAPA responses.
    • Need to conduct qualification, verification, and validation activities to produce medical devices.
    • Work with CFT teams in troubleshooting problems on the production floor.
    • Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.
    • Drive the execution of various validation and PFMEA activities as per the project plan
    • Application of statistical and analytical methods such as SPC, SQC and DOE.
    • Contributor to the Capital Expense Request (CER) process, specify cost for Packaging/Labeling/ sealing equipment with consideration to product standard cost targets and capacity demands.
    • Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA.
    • Execute Site acceptance test and Factory acceptance test based on North Haven
    • Execute Validation Gap analysis of various product families based in Medtronic
    • Plan and initiate CDPs associated with the various validation activities
    • Co-ordination with stakeholders
    • Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA.

    Qualification:

    • BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering
    • Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.
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