Quality Engineer - Temecula, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Temecula, United States

    Found in: Appcast US C2 - 1 week ago

    GForce Life Sciences background
    Description

    Quality Engineer on-site in Temecula, CA

    Summary

    Our client, a Fortune-500 medical device company, is looking for a Quality Engineer to provide support to product development teams (Design Controls) in their Vascular unit on-site in Temecula, CA.

    Term & Start

    • 11-month contract, starting 4/29/24
    • On-site in Temecula, CA
    • Pay Rate: $35-40/hr ($70-80k annually)
    • FT hours, M-F 8a-5p
    • Business Unit: Vascular

    Main Duties

    Authors and reviews/approves protocols and report to support Design Controls deliverables

    Performs data analysis to support product development studies

    May be responsible for creating risk assessment documentation

    May be responsible for test method validation

    Develops/implements process monitoring requirements and documentation

    Identifies and controls Manufacturing process defects by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions

    Creates product specifications, quality specifications and quality plans in conjunction with other product development team members

    Plans, organizes, and prioritizes own daily work routine to meet established schedule

    Mandatory Requirements to Succeed in Role

    BS in Engineering

    Medical device regulation/guidance (FDA, ISO)

    Experience with the following:

    o Risk management

    o Test method validation

    o Design Verification (Filing and Aging studies)

    o Process validation

    o Data analysis (JMP)

    o Statistical equivalence studies