**Description:**

As a Quality Engineer on our Fluke Health Solutions Quality Assurance/Regulatory Affairs team, you will be responsible for ensuring compliance with established FDA/GMP/QSR and ISO 9001/13485/17025 and other applicable regulatory standards and requirements.  Failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.

**Your primary contacts will be:**

Internal **:** Quality Assurance and Regulatory Affairs team, Operations team, Engineering team, Business Units as well as all other functional team members.

External **:** Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers.

 

**Responsibilities:**

+ Ensure appropriate document control process is in place as it relates to medical activities.

+ Handle Complaints, Non-Conformances, Cor...