Insulet Corporation

  • Supplier Quality Engineer

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 4 weeks ago(5/29/2018 10:22 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    Supports the selection, qualification, and management of external finished goods suppliers to Insulet.  Closely works with component manufacturers and service suppliers to ensure product / service quality meets Insulet requirements. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, Information Technology, and Regulatory Affairs) as well as with suppliers and other external parties on issues related to product quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.

    Responsibilities

    • Maintain approved supplier list and supplier history records in accordance with quality Plans and conducts scheduled audits of suppliers to assess compliance with Insulet requirements
    • Conducts and confirms follow-up actions on Supplier Quality System Audits
    • Leads project teams for Supplier Selection activities and Supplier Risk Mitigation
    • Assesses supplier capabilities through direct visits, technical discussions and Quality System Audits
    • Prepares detailed trip reports and Audit Reports to document audit findings and observations
    • Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions
    • Generate, review, and implement Supplier Quality related policy/procedure/ and guideline development
    • Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility
    • Tracks and trends supplier performance via supplier scorecards, taking remedial action as needed
    • Maintains accuracy of Supplier Audit Reports and Supplier Profile
    • Provides guidance to Purchasing and Engineers in applying supplier quality system requirements
    • Contributes and participates in supplier performance reviews
    • Trains suppliers, auditors, and other Insulet personnel on QA specifications for suppliers
    • Supports the development of Supplier Quality infrastructure by working with management on the development and enhancement of critical processes and procedures, as well as training and mentoring less experienced auditing staff
    • Performs other duties as required

    Education and Experience

    • Bachelor’s degree in an engineering or science related field
    • Minimum of 2 years’ experience auditing in a regulated industry is preferred
    • Experience leading supplier quality related improvement projects is preferred
    • Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards
    • Auditor training certification to ISO 13485, 17025, or other industry QMS Standard, is preferred

     

    Skills/Competencies:

    • Effective verbal and written communication skills
    • Ability to communicate at multiple levels of an organization
    • Computer skills: Word processing, spreadsheet, database
    • Ability to organize and judge priorities
    • Ability to generate and maintain accurate records
    • Knowledge of basic statistical and quality control principals
    • Ability to lift up to 20 pounds

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