Senior Quality Engineer Post Market Surveillance and Trending ;
MedtronicAbout the role
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
Careers That Change Lives
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to
alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Senior Quality Engineer in Medtronic’s Surveillance process within the quality organizations, the incumbent will contribute to the Post Market Surveillance document writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering, technical, medical) writing position. This individual will partner with other teams such as Quality/Reliability, Clinical, Regulatory Affairs, Product Development, Medical Safety, and Statisticians to collaborate and execute tasks in a timely manner.
Responsibilities may include the following and other duties may be assigned.
Contributes and authors Post Market Surveillance, plans and report documents.
Develop therapy and product knowledge and apply this knowledge to surveillance of products.
Lead or participate in project teams to meet objectives related to process improvement, hyperautomation (AI and machine learning) and overall strategy and timing of day to day work.
Provide input and feedback to ensure clear, concise complete reports.
Collaborate with cross-functional team to assure high quality and successful completion of deliverables
Report on schedule, timelines and deliverables
Author and lead cross functional team to review collected safety communications and compiled reports
Review inputs to annual reports summarizing CAPA, FCA and IIA information
Review of key data elements to ensure no changes and consistency across various reports.
Contribute or participate in drafting responses to deficiencies from regulatory agencies.
Participate in review activities and approval of other documents authored by another function
Escalate and evaluation of signals during annual reporting
Qualifications
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree in Engineering
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