Job Description
**Join Our Team as a Quality Engineer!**
As a (Senior) Quality Engineer (m/f/d) you will be responsible for Adverse Event Reporting, focusing on MDRs, as well as playing a crucial role in Stryker Leibinger Instruments Recall/FSCA processes, ensuring product safety and compliance within the global regulatory Post Market landscape.
**What will you do**
+ You will be responsible for creating and submitting MDRs in compliance with FDA’s CFR 21, part 803 requirements (Medical Device Reporting).
+ You will review, assess and keep overview of all incoming and open product complaints that need to be evaluated for reportability in order to ensure reporting in the required timeframes.
+ You will be closely collaborating with clinicians and other Post Market Functions in order to accurately assess reportability decisions in line with the associated (medical) risk assessment. For events that do not meet...
As a (Senior) Quality Engineer (m/f/d) you will be responsible for Adverse Event Reporting, focusing on MDRs, as well as playing a crucial role in Stryker Leibinger Instruments Recall/FSCA processes, ensuring product safety and compliance within the global regulatory Post Market landscape.
**What will you do**
+ You will be responsible for creating and submitting MDRs in compliance with FDA’s CFR 21, part 803 requirements (Medical Device Reporting).
+ You will review, assess and keep overview of all incoming and open product complaints that need to be evaluated for reportability in order to ensure reporting in the required timeframes.
+ You will be closely collaborating with clinicians and other Post Market Functions in order to accurately assess reportability decisions in line with the associated (medical) risk assessment. For events that do not meet...
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