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    Quality Manager - Dayton, United States - Resonetics

    Resonetics
    Resonetics Dayton, United States

    1 week ago

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    Description


    The Quality Manager provides customer-and factory-facing quality support for contract manufacturing of medical device components at a specific Resonetics site.

    The position includes managing the interface between Resonetics and customers' supplier quality organization, assisting with transition and sustaining of manufacturing processes, and support for supplier quality management.


    The Quality Manager also acts as the lead person for a manufacturing site for all Quality and Regulatory matters and supervises other quality personnel on site.

    The Quality Manager oversees the site Quality department budget, Quality personnel hiring for the site, and establishes site-level policies to comply with Resonetics-wide directives.

    The Quality Manager is responsible for implementing new and revised corporate quality systems documents.

    The Quality Manager is the Resonetics site Management Representative and leads facilitation of external audits.

    The Quality Manager position uses Quality Engineering techniques including:

    Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, and ISO compliance.


    RESPONSIBILITIES:
    Performs and supports the work using quality risk management principles and their application to medical device manufacturing.

    Liaising with customer quality personnel to resolve issues and Customer Complaints

    Monitoring and disseminating customer quality report cards

    Generating process deviations, validation protocols and reports

    Generating Customer Change Notices

    Assisting with troubleshooting of production and process development processes

    Leading development of metrology equipment

    Developing and maintaining quality/control plans

    Developing PFMECAs

    Specifying metrology equipment

    Conducting Gage R&R studies

    Resolving Corrective and Preventive Actions

    Developing Quality Procedures and ensure training of personnel

    Approving Nonconformance disposition

    Analyzing production and validation data

    Working on continual improvement and process assessment projects as assigned

    Supervising quality department for a site


    REQUIRED QUALIFICATIONS:
    Minimum 8 years' experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience

    Demonstrated technical writing and communication skills.

    Have proven experience leading the facilitation of external audits

    Working knowledge of 21 CFR Part 820 and/or ISO 13485 compliance

    Working knowledge of Statistical software and/or Minitab

    Bachelor's degree or equivalent experience

    Prior supervisory experience


    PREFERRED QUALIFICATIONS:
    Prior engineering management experience

    CMQOE, CQE and/or Six Sigma Green or Black belt

    Bachelor's degree in engineering/science discipline


    PHYSICAL DEMANDS:
    Position may include up to 10% domestic and international travel

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