Insulet Corporation

  • Quality Engineer

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 3 weeks ago(9/29/2018 4:26 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    This position is an integral part of Insulet's Quality Department. It requires creativity and foresight to work with other functions to ensure compliance and the accomplishment of departmental and company goals. Works with engineering, purchasing, Suppliers, and manufacturing to support the manufacturing operations and continuous improvement initiatives.

    Responsibilities

    • Maintain company compliance of FDA Quality System Regulations and ISO 13485 standards.
    • Work with operations/manufacturing and the contract manufacturer to lead efforts to resolve issues that involve quality system gaps, production nonconformances or situations that involve component qualification or procurement.
    • Conduct failure and hazard analysis for manufacturing support and Supplier process improvement.
    • Enhance quality system processes as it pertains to management of assigned deliverables to ensure compliance.
    • Be an active lead auditor, participating in external supplier audits and internal audits.
    • Develop and/or manage some quality programs related to resolution of issues arising from manufacturing operations as well as post manufacturing activities. Provide QA Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions, as it relates to Supplier Quality.
    • Establish ownership responsibilities for issues and nonconformances and develop expertise in Master Control to coordinate resolution of the issues and nonconformances.
    • Develop and document Quality processes, procedures, and test methodologies.
    • Work with and guide the team performing final product testing and release to ensure deliverables of product release are met.
    • Maintain company compliance to FDA Quality System Regulations and ISO 13485 standards.
    • Support activities as it pertains to sterilization release, sterilization validation, biocompatibility, design verification, design validation and other associated validation and qualification activities.
    • Manage test protocol & report development for validations as applicable.
    • Prepare reports related to Quality Metrics and identify and implement improvements towards meeting those goals.
    • Actively work within the CAPA system, provide inputs to the CAPA Review Board and Monthly Data Analysis.
    • Perform other duties as assigned.

     

    Education and Experience

    • BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
    • Minimum of 2 years in the Medical Device Industry preferred.
    • Experience with FDA and ISO 13485 inspections.

     

    Preferred Skills/Competencies:

    • Minimum of 3 years in the Quality function working with QSR and ISO 13485 preferred.
    • Effective verbal and excellent technical writing skills.
    • Ability to communicate and work effectively at multiple levels within the organization.
    • Ability to organize and judge priorities.
    • Excels at generating and maintaining organized and accurate records.
    • PC skill, word processing, spreadsheet, database.

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