• Manager, Quality Engineering

    Cook Medical (Bloomington, IN)


    Overview

     

    The Manager, Quality Engineering at Cook Polymer Technology is responsible for developing/managing systems that ensure regulatory compliance and the mitigation of potential risks due to quality related issues.

    Responsibilities

    + Manages the execution of Quality Engineering functions including oversight of CAPA program, oversight of supplier quality program, oversight of production monitoring, oversight of risk assessments.

    + Review and approve change request, equipment and tooling qualifications.

    + Oversight of production inspection activities including methods development, Prolink, and MSA studies.

    + Oversight of IQC activities.

    + Oversight of calibration activities.

    + Support validation related activities.

    + Support customer inquiries regarding compliants, quality systems validation status.

    + Support nonconformance review Material Review Board

    + Support external audits

    + Publish monthly metric/key process indicators.

    + Develop and distribute management meeting packets including PDR, and management review.

    Qualifications

    • Bachelor's degree in Engineering or technical field. • 5+ years of work related to quality assurance, quality engineering, quality tools and principles includng root cause analysis. • Understanding of principles of quality assurance and quality engineering. • Understanding of risk mangement and mitigation activities throughout the product realization process.

    • Proficient at leading effective CAPA program.

    Physical Requirements:

    • General office environment Demonstrated Project• Sedentary Work, Exerting up to 10 punds of force occasionally. Involves long periods of sitting.• Requires close visual acuity when working with computers, equipment etc.This job description reflect managements assignment of essential functions; and nothing herein restricts management's right to assign or reassign durites and responsibilities to this job at any time.

     

    Requisition ID2025-16124

     

    Posting Date2 weeks ago(5/20/2025 5:20 PM)

     

    Job Location(s)Bloomington IN United States

     

    Job LocationsUS-IN-Bloomington

     

    TravelLess than 10%

     

    Shift Type1st shift

     

    Position TypeFull Time

     

    CompanyCook Inc - Bloomington

     

    CategoryQuality