Abbott
Healthcare
SeniorSoftwareDesignAssuranceEngineer
“Senior Software Design Assurance Engineer at Abbott. Skills: Software quality, Design assurance, Regulatory compliance. Provide technical and quality system guides. Provide quality oversight for software verification”
Industry & Context.
Problem resolution systems
5% travel
What They're Looking For.
Must Have
Bachelor's degree in engineering, Minimum 5 years related work experience, Knowledge of regulations affecting medical software, Verbal and written communication skills
Nice to Have
Advanced degree, Previous quality engineering experience, Demonstrated use of quality tools/methodologies, Experience in broader enterprise business unit
What You'll Do.
Provide technical and quality system guides
Provide quality oversight for software verification
Provide quality oversight for software validation
Review and approve software test case protocols
Review and approve software test case reports
Review software development plans
Review system documentation
Review software documentation
Lead meetings to prioritize issues
Lead meetings to review issues
Lead meetings to approve action plans
Lead risk evaluation activities
Lead risk management activities
Participate in technical reviews
Participate in management reviews
Represent quality engineering function
Approve designated design outputs
Provide quality oversight for non-product software
Assess need for validation
Prepare protocols for validation
Support protocols for validation
Prepare reports for validation
Support reports for validation
Support product cybersecurity assessments
Comply with US FDA regulations
Comply with country regulatory requirements
Comply with company policies
Comply with company procedures
Maintain collaborative partnership
Develop training for company personnel
Conduct training for company personnel
Lead quality system improvement activities
How You'll Work.
Team & Collaboration
Cross-functional team members; R&D collaboration
Communication Scope
Verbal communication; Written communication
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