Lead Quality Assurance Specialist
2 weeks ago
Position Overview: The Senior Quality Assurance Engineer at Omni Inclusive plays a crucial role in overseeing design control for various software, system, and hardware development initiatives.
This hybrid role is part of the Development Quality Software team.
Key Responsibilities:
- Ensure adherence to relevant regulatory agency requirements, established standards, company policies, and project-specific plans.
- Guide project teams on specific processes and deliverables, ensuring that essential elements of product development are documented appropriately.
- Prepare necessary documentation in line with product development processes and Software Development Life Cycle requirements, ensuring compliance with regulatory standards.
- Maintain an organized and complete Design History File (DHF) that is auditable and supports regulatory product registration needs.
Essential Qualifications:
- Bachelor's degree in Software Engineering or a related technical field with a minimum of 5 years of experience in the IVD, Medical Device, or Biotechnology sectors.
- Alternatively, a Master's degree in a scientific field with at least 3 years of experience, or a Doctoral degree with 0-2 years of experience.
Preferred Skills:
- Familiarity with US and International regulations and standards.
- Knowledge of design control, risk management, and software development processes.
- Experience in the medical device industry within a Quality Assurance capacity is advantageous.
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