Quality Engineer I

Prolaio•Chicago, IL

10d•Hybrid

About The Position

The Quality Engineer I is responsible to support production activities including Quality Control activities for components and suppliers, in-process and finished goods inspection and release, and the transfer of products/processes from Design to Production. This role reports to the Director, Quality Management Systems working on the Regulatory, Quality, and Clinical Development Operations Team. This is a hybrid role based in our Chicago office.

Requirements

Experience with ISO 13485 and CFR Part 820
Working knowledge of regulatory inspections/audits

Nice To Haves

CAPA experience is a plus
Passionate about what you do and excited about contributing your skills to enable better healthcare through technology.
Humble, kind, and keen to receive and act on feedback, excited to help your teammates, and celebrates the success of your team.
Can work independently with minimal supervision and proactively identify and mitigate future challenges.
Are a critical thinker and creative problem solver who can collaborate effectively with individuals internally and externally.
Eager to learn and grow and is not afraid of challenging and complex work.

Responsibilities

Ensure specifications for components are complete and accurate prior to acceptance activities.
Ensure suppliers for components and services that may impact product quality are formally qualified and documented as such.
Perform quality inspections of finished goods and device history records, and release goods, if accepted.
Support environmental monitoring activities.
Work with Design and Production teams to ensure the successful transfer of products and processes from Design to Production.
Support Complaint process by organizing investigations , if required, to ensure timely completion and documentation.
Perform monitoring and measurement activities , reporting regularly to the Director, QMS, and to Management via Management Review processes.