TechDigital
Senior Quality Assurance Engineer
TechDigital, Minneapolis, Minnesota, United States, 55400
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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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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