Quality Assurance Engineering Manager
2 days ago
We are looking for a Quality Assurance Engineering Manager to join our team at Omni Inclusive. This role will provide design control oversight to various software/system/hardware development projects and ensure compliance with regulatory requirements.
This is a hybrid position part of the Development Quality Software team and will be located in Chaska, MN. As a key member of our US Diagnostic Development Quality team, you will report to the Manager, Quality Assurance, responsible for software projects.
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.
The estimated annual salary for this position is around $120,000-$150,000, based on industry standards and the location.
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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