Quality Engineer

Job Description

Job Description

Title : Quality Engineer
Location : Chicago, IL (Ravenswood area)
Hire Type : 1+ year long contract

Hybrid - 1-2 days work from home  

Benefits : As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

Build the Validation Strategy for a New Medical Device Program

We’re seeking a hands-on Quality Engineer to support the launch of a new assembly program for drug delivery devices.

This is a unique opportunity for someone who enjoys building quality and validation processes from the ground up. The operation is currently manual/semi-automated and is essentially an engineering prototype at scale as the team prepares for future automation.

You’ll help establish in-process quality controls, batch release processes, and IQ/OQ/PQ validation while determining how manufacturing processes should be controlled and how process risks impact overall product quality.

What You’ll Do

• Develop and execute IQ/OQ/PQ process validations.
• Establish in-process quality controls and batch release processes.
• Support the launch of a new medical device assembly program.
• Identify quality checkpoints and controls within manual/semi-automated processes.
• Assess process risks and their impact on product quality and performance.
• Partner with Manufacturing, Engineering, Quality, and Product Development.
• Develop validation protocols, reports, and supporting documentation.
• Support troubleshooting and continuous improvement activities.

What We’re Looking For

• Strong experience with IQ/OQ/PQ manufacturing validation.
• Medical device or other regulated manufacturing experience preferred.
• Background in Product Development, NPI, Process Engineering, or Manufacturing Quality is a plus.
• Experience with manual or semi-automated assembly processes.
• Strong understanding of process controls and product risk.
• Creative, hands-on problem solver comfortable building processes from scratch.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.