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Quality Engineering

Senior Quality Assurance Engineer

Job in Minneapolis, Hennepin County, Minnesota, 55400, USA
Listing for: TechDigital Group
Full Time position
Listed on 2026-01-12
Job specializations:
  • Engineering
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 125000 - 150000 USD Yearly USD 125000.00 150000.00 YEAR
Job Description & How to Apply Below

Description/Comment: The Senior Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible for providing design control oversight to various software/system/hardware development projects.

This is a hybrid position part of the Development Quality Software team and will be located in Chaska, MN.

You will be a part of the US Diagnostic Development Quality team and report to the Manager, Quality Assurance, responsible for software projects. If you thrive in a multifunctional, fast-paced role and want to work to build a world-class Quality organization—read on.

In this role, you will have the opportunity to:

  • Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
  • Provide guidance to project teams on project specific processes and deliverables. Ensure key elements of product developments are documented in design and development plan or design change plan.
  • Prepare documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as FDA, ISO 13485 standards.
  • Ensure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.

    • The essential requirements of the job include:

  • Bachelor's degree in Software Engineering or related technical field with 5+ years' experience in IVD, Medical Device, or Biotechnology organization preferred OR Master's degree in a scientific field with 3+ years' experience OR Doctoral degree with 0-2 years' experience.
  • Working knowledge of US and International regulations and standards.
  • Familiar with design control, risk management and software development processes.

    • It would be a plus if you also possess experience in:

  • Experience with the medical device industry within a Quality Assurance is preferred.
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    Position Requirements
    10+ Years work experience
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