Medtronic
Healthcare
QualitySystemsAnalyst
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Systems Analyst at Medtronic. Skills: Post Market Vigilance, Regulatory Affairs, Quality Systems. Support Brazil Post Market Vigilance activities. Ensure Medical Device Reports are submitted timely to”
Industry & Context.
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
Full Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** We are leaders in medical technology and solutions, driven by a mission and built on a legacy of integrity and innovation. We are searching for a Quality Systems Analyst to help improve patient care and collaborate across the industry to make healthcare more affordable and accessible. Be part of a community of experts committed to advancing high-quality, cost-effective healthcare worldwide. The Quality Systems Analyst will support Brazil Post Market Vigilance activities related to Product Complaint Handling. The successful candidate will be focusing on Reportability Decisions and MDR processes in Regions Quality Post Market Vigilance for the country. We are offering a flexible working arrangement with presence in our office in São Paulo, Brazil. **Responsibilities may include the following and other duties may be assigned.** * Ensure Medical Device Reports are submitted timely with high-quality of information to ANVISA. * Maintain stability and efficiency of Regions Quality PMV processes with an intention to improve and refine the process. * Improve Vigilance timeliness performance. * Ensure PMV activities are executed as defined in applicable quality documents. * Responsible for the execution, monitoring, and closure of Vigilance activities throughout LATAM. * Responsible for the implementation and maintenance of quality metric and monthly reports on PMV activities. * Ensure that the Company’s agreed quality standards (including ISO13485) are maintained with regards to products, procedures, policies, operations, and customer contact. * Provide support and services to the Brazil local QARA based on defined Service Level Agreement. **Required Knowledge and Experience:** * Bachelor's Degree required in Med
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