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.
Is this your next job Read the full description below to find out, and do not hesitate to make an application.
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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