Abbott
Healthcare
QualityAssuranceEngineerII
“Quality Assurance Engineer II at Abbott. Skills: Quality Assurance, Design Controls, Medical Devices. Drive alignment in cross functional meetings. Act as QA representative”
Industry & Context.
Root-cause analysis
Continuous sitting, Keyboard use
What They're Looking For.
Must Have
BS in engineering or related field, 3+ years of Quality experience, Prior Medical Device industry experience
Nice to Have
Mechanical or Biomedical preferred, Design Controls - Design for Manufacturability, Statistical Analysis experience, Calibration/Preventative Maintenance experience
What You'll Do.
Drive alignment in cross functional meetings
Act as QA representative
Review and approve engineering changes
Collaborate with R&D and Marketing
Support mobile app deployment activities
Drive alignment during cross functional review
Approve impact assessments
Approve root-cause analysis investigation
Review and approve batch records
Ensure Device History File compliance
Ensure Device Master Record compliance
and monitor quality information
Participate in internal & external audits
Ensure audit responses are submitted
How You'll Work.
Team & Collaboration
Cross functional meetings; R&D and Marketing
Process & Methodology
Design planning
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