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    Senior Quality Engineer - San Jose, United States - miraDry, Inc.

    miraDry, Inc.
    miraDry, Inc. San Jose, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Position Summary:

    Oversees Quality Engineering responsibilities, handling areas such as New Product Development Quality, Corrective and Preventive Actions, Temporary Deviations, Risk Management, Nonconforming Material, Material Dispositions, and Standards Management.

    Key Responsibilities:

    • Adhere to miraDry Inc's quality system requirements and relevant regulatory standards
    • Ensure compliance with health and safety regulations and policies
    • Efficiently manage Quality Engineering & associated activities
    • Establish and maintain processes for updates to Standards and ensure state-of-the-art maintenance
    • Oversight of the Device Master Record (DMR)
    • Assist senior Quality and Manufacturing personnel in handling nonconforming material controls
    • Manage equipment systems and conduct defect awareness training
    • Present quality trend analyses and reports through established processes
    • Perform inspections and data reviews
    • Create and approve test protocols, reports, and rework instructions
    • Lead software change controls and problem reporting
    • Provide quality engineering support across product development, manufacturing, and service
    • Assess practices against external standards and regulations
    • Conduct internal and supplier quality audits
    • Oversee risk management and participate in hazard analyses
    • Maintain awareness of FDA and international regulations applicable to company products
    • Manage projects, resource allocation, and adherence to schedules
    • Participate in new product planning and risk analysis
    • Support team building and morale within the department and company
    • Offer guidance to teammates
    • Coordinate with team members to ensure protocol and regulatory compliance
    • Travel requirement: up to 10% domestic and international

    Education and/or Experience:

    • Bachelor's Degree in an Engineering field
    • Minimum 5 years of Quality Engineering experience in the medical device sector
    • Experience with FDA Class II Medical Devices

    Required Competencies:

    • Training on miraDry, Inc. quality system requirements
    • Knowledge of relevant ISO standards, regulatory requirements, and risk management techniques
    • Proficiency in word processing and spreadsheet programs
    • Strong problem-solving skills and ability to work in a team
    • Effective planning, organization, and communication skills
    • Ability to manage multiple priorities

    *Remuneration is commensurate with experience

    FLSA Status: Exempt

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