Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an Impact:
Fulfill applicable medical device regulations in the region, ISO13485 and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
Investigate complaints with the support of higher level team member or manager
Evaluate event to determine if it qualifies as a complaint
Manage customer relationship and expectations during course of complaint investigation and resolution process
Assess complaint information provided and conduct additional investigation as needed and escalated as appropriate
Evaluate complaints for Medical Device Reporting to competent authorities
Prepare and submit reports to Competent Authorities, after review by more senior team member
Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
Prepare and submit final customer correspondence, after review by more senior team member
Other incidental duties; May identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered
What you will need (Required):
Bachelor's Degree in related field, 1 years experience with complaint handling experience
Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical prod