Senior Quality Assurance Engineer - TechDigital
Minneapolis, MN
About the Job
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
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
Source : TechDigital
