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Quality Engineer


Posted Monday, May 15, 2023

Posting ID: JP-003776433

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Minneapolis, MN
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Job Description:

  • Directly support product realization from material acquisition to product build/test/release to delivery/service to returns.
  • Provide day-to-day direction of technicians/inspectors and engineers. 
  • Activities include CAPA execution, complaint investigation, inspection and test method development, implementation of manufacturing process controls including process validation, sterile load prep and release and risk management. 
  • This role will execute and finalize special projects to continuously improve product and process quality as well as quality system improvements.

Job Responsibilities:

  • Prioritize incoming, in-process, and final acceptance testing to meet Quality Standards and Business needs.
  • Develop Inspection Procedures in collaboration with Technicians/Inspectors, Supplied Quality, Sustaining and Development groups as applicable.
  • Review Quality Records for accuracy and completeness.
  • Create and maintain control plans for products that includes inspection from components through finished goods.
  • Resolves first level manufacturing and technical issues in a timely manner via NCR process.
  • Work with cross-functional leadership in identifying, prioritizing, communicating, and resolving quality issues and opportunities for improvement.
  • Maintain NCR Trending metrics to identify opportunities for improvement.
  • Perform Sterile Load preparation and release.
  • Assists with returns decontamination, complaint investigation/analysis and final release of sterile products including collaboration with contract manufacturers as applicable.
  • Performs process validation planning and execution, revalidation assessments.
  • Assists withb design transfer of new product into production


Quality engineering, Root cause analysis, CAPA, ISO 13485, Quality assurance, design transfer, NCR

Additional Skills & Qualifications:

  • Bachelor's Degree
  • 2+ years experience in Quality Assurance within the medical device industry
  • Knowledge of medical device regulations and standards:
    • FDS QSR (21 CFR Part 820)
    • Health Canada (CMDR)
    • ISO 13485
  • Experience with MiniTab including Measurement System Analysis (Gage R&R, Attribute Agreement Analysis), charting, normality, capability analysis etc.
  • Experience using Agile Product Lifecycle Management (strongly preferred but not required)
  • Strong attention to deatail and experience with Good Documentation Practice (GDP)
  • Demonstrated proficiency with MS Office and Adobe Acrobat

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