Job Description
Job Title: Quality EngineerJob Description
The Quality Engineer provides expertise and leadership in post-market surveillance for finished medical devices, with a strong focus on root cause analysis, risk assessment, failure mode determination, product reliability, and ongoing product performance monitoring. This role collaborates closely with Development, Operations, Manufacturing, Quality, and global field teams to ensure that all activities comply with internal procedures and applicable geographic regulations. The position requires flexibility to manage changing priorities, the ability to work independently with minimal supervision, and strong leadership in driving quality improvements for electromechanical medical devices.
Responsibilities
+ Lead the product reporting and complaint handling process for assigned products, including initial evaluation, escalation, risk evaluation, investigation, root cause determination, product disposition, and report closure.
The Quality Engineer provides expertise and leadership in post-market surveillance for finished medical devices, with a strong focus on root cause analysis, risk assessment, failure mode determination, product reliability, and ongoing product performance monitoring. This role collaborates closely with Development, Operations, Manufacturing, Quality, and global field teams to ensure that all activities comply with internal procedures and applicable geographic regulations. The position requires flexibility to manage changing priorities, the ability to work independently with minimal supervision, and strong leadership in driving quality improvements for electromechanical medical devices.
Responsibilities
+ Lead the product reporting and complaint handling process for assigned products, including initial evaluation, escalation, risk evaluation, investigation, root cause determination, product disposition, and report closure.