Senior Quality Assurance Engineer

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 :

OR Master's degree in a scientific field with 3+ years' experience OR Doctoral degree with 0-2 years' experience.

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