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Linux engineer • chicago il

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Quality Engineer

Quality Engineer

Sterling Engineering, Inc.Chicago, IL, US
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Quality Engineer (Manufacturing Validation)

? Chicago, IL (Hybrid)
? $45–$60/hr
? 6-Month Contract (Potential for Extension)

Company Overview
Nemera is a global contract manufacturer specializing in drug delivery devices for the pharmaceutical and biotechnology industries. Their Chicago team is launching a new assembly program focused on subassembly systems for drug delivery products and is seeking a hands-on Quality Engineer to support this critical initiative.

Position Overview
This role is heavily focused on Manufacturing Quality and process validation. The team has incoming inspection established but needs support building and implementing batch release processes, in-process quality controls, and overall operational quality flow. This is a ground-up validation effort — no validation structure is currently in place — making this an excellent opportunity for someone who enjoys building systems from scratch.

The environment is currently manual and semi-automated, operating much like an engineering prototype at scale before full automation is introduced. This role requires a creative, problem-solving mindset and strong understanding of how manufacturing processes tie into product risk and overall device performance.

Key Responsibilities
  • Develop and execute IQ/OQ/PQ process validations for manufacturing operations
  • Establish in-process quality controls and batch release processes
  • Support the launch of a new assembly program for drug delivery subassemblies
  • Define where quality checkpoints belong within a manual/semi-automated manufacturing flow
  • Assess process risks and understand product impact (e.g., missing components, assembly defects, etc.)
  • Collaborate cross-functionally with Manufacturing and Product Development teams
  • Support documentation and administrative work (remote flexibility available for this portion)
Ideal Background
  • Strong experience validating manufacturing processes (IQ/OQ/PQ required)
  • Experience in medical device manufacturing preferred
  • Background in Product Development is highly desirable
  • Experience working in semi-automated environments
  • Ability to understand process control and product risk relationships
  • Comfortable working in early-phase or “prove-out” production environments
  • Hands-on, creative problem solver who can build validation systems from the ground up
Work Arrangement
  • Mostly onsite in Chicago
  • Remote flexibility available for documentation/admin work once established (approx. 3 days/week onsite after ramp-up)
Contract Details
  • 6-month contract
  • Pay: $45–$60/hr
  • Potential for extension based on performance and project needs


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.