Medtronic
Healthcare
QualitySystemsAnalyst
“Quality Systems Analyst at Medtronic. Skills: Post Market Vigilance, Reportability Decisions, MDR processes, ISO 13485. Support Brazil Post Market Vigilance activities. Ensure Medical Device Reports are submitted timely to”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Bachelor's Degree in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline, 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role, Advanced English language, Computer literacy including MS Office Suite or software, Good understanding of GDP and its implementation, Sound awareness and knowledge of ISO 13485 and its implementation
Nice to Have
Experience in regulatory requirements for adverse event reporting for approved devices, Experience in writing comprehensive regulatory reports
What You'll Do.
Support Brazil Post Market Vigilance activities
Ensure Medical Device Reports are submitted timely to
Maintain stability and efficiency of Regions Quality PMV
Improve Vigilance timeliness performance
Ensure PMV activities are executed as defined
and close Vigilance activities throughout LATAM
Implement and maintain quality metric and monthly reports
Ensure Company’s agreed quality standards are maintained
Provide support and services to the Brazil local
How You'll Work.
Team & Collaboration
Collaborate across the industry; Support Brazil local QARA
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