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  • Associate Software Supplier Quality - Greater Minneapolis-St. Paul Area - Planet Pharma

    Planet Pharma
    Planet Pharma Greater Minneapolis-St. Paul Area

    2 months ago

    $60,000 - $85,000 (USD) per year *
    Description

    Job ID: 621745

    ***Please Note - This is an onsite role in the Minneapolis area - please only apply if you are either local to Minneapolis or plan to move there on your own without monetary assistance***

    Our client, a leading Medical Device company, is seeking a Junior-level hybrid Software Supplier Quality and Reliability Engineer who will split their time managing 3rd party software suppliers (could be libraries or software components that get embedded in devices or software used in manufacturing of products, such as: developer tools, compilers, etc) and the other half handling software reliability. See below for other details

    Top 3 Skills Needed:

    • Supplier Quality (software), Knowledge of QMS, Knowledge of Risk Management Processes

    Job Description:

    • Supplier onboarding, quality risk assessments, FMEA (failure mode effects analysis)
    • Managing 3rd party software suppliers- could be libraries or software components that get embedded in devices or Could to tools or software used in manufacturing of products (developer tools, compilers, etc)
    • Onboarding new software suppliers – interface with supplier, get them to fill out survey that tells Medtronic what kind of supplier they are and their business liability/quality controls.
    • Conducts risk assessments – collaborates with other SMEs looking at risks the company of products failing.
    • Handle all documentation in QMS to register supplier as approved supplier. Also potential to support audits
    • Use PLM system daily
    • Ensures that suppliers deliver quality parts, materials, and services.
    • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
    • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur.
    • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
    • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

    Requirements:

    • 1-3 years of applicable experience
    • Bachelor's Degree within an Engineering realm
    • ISO13485 experience; supplier quality experience preferred. Would like for this person to have some type of a software background so they speak to products with the 3rd party suppliers; Software QA background ; may consider component/consumables experience in lieu
    • Experience working with vendors and suppliers
    • Familiarity with software of unknown provenance (SOUP) components and SOUP validation.
    • Use of Excel, Access, SharePoint and site builder
    • Experience with routing change orders in a document management tool such as Agile MAP
    • Familiarity with the New Product Development (NPD) process
    • Risk Management experience
    • Written and oral communication skills, including the ability to summarize complex technical concepts and problems clearly and concisely.
    • Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices
    * This salary range is an estimation made by beBee
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