Job Description
Title: Quality Engineer
Location: Chicago, IL (Ravenswood area)
Hire Type: 1+ year long contract
Hybrid - 1-2 days work from home
Compensation: $45-60/hr (potentially more depending on experience)
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.
Numbers & Facts
| Location | Chicago, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $45–$60 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1969 |
| Website | http://www.sterling-engineering.com |
About Company
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
Skills
- Automationunmatched
- Continuous Improvementunmatched
- Documentationunmatched
- Drug Delivery Devicesunmatched
- Identify Issuesunmatched
- Manufacturingunmatched
- Manufacturing/Industrial Processesunmatched
- Medical Equipmentunmatched
- Process Analysisunmatched
- Process Control Engineeringunmatched
- Process Engineeringunmatched
- Process Qualityunmatched
- Process Validationunmatched
- Product Developmentunmatched
- Product/Service Launchunmatched
- Prototypingunmatched
- Quality Engineeringunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Validation Planunmatched
- Work From Homeunmatched
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