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Quality Engineer Software Validation Jobs in Illinois

Sigan America LLC

Validation Engineer

Ottawa, IL · On-site

$90K - $100K/yr

Ensure compliance with FDA cGMP regulations, ISPE guidance, and internal quality standards ... Experience with software validation and 21 CFR Part 11 compliance. * Experience completing ...

TEKFORTUNE INC

Quality Engineer - SDET

Chicago, IL · On-site

They are seeking a Quality Engineer with strong experience in Playwright automation and proficiency with JIRA for test management. Responsibilities : • Strong experience with Playwright automation ...

Sterling Engineering Inc.

Quality Engineer

Chicago, IL · Hybrid

$45 - $60/hr

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 ...

Spirax-Sarco Engineering

Quality Engineer

Cary, IL · On-site

$73K - $94K/yr

As the Quality Engineer (QE), youwill provide quality engineering and direct customer coordination andleadership for production quality and validation of manufacturing processes.Provides ...

Pursuit Aerospace

Quality Engineer

Morton, IL · On-site

$68K - $88K/yr

About the Opportunity: As a Quality Engineer I, you will provide support to operational and ... validation, and customer specifications. * Experience working with CAD, QMS and ERP software.

Pursuit Aerospace

Quality Engineer

Morton, IL · On-site

$68K - $88K/yr

About the Opportunity: As a Quality Engineer I, you will provide support to operational and ... validation, and customer specifications. * Experience working with CAD, QMS and ERP software.

Spirax-Sarco Engineering

Quality Engineer

Cary, IL · On-site

$80K/yr

As the Quality Engineer (QE), you will provide quality engineering and direct customer coordination and leadership for production quality and validation of manufacturing processes. Provides ...

Mason

Quality Engineer

Chicago, IL · On-site

$74K - $95K/yr

Quality Reports to: Director of Quality FLSA Status Exempt EEOC Class: Craft Worker Summary The ... Support First Article Inspection (AS9102) activities and product validation. * Review engineering ...

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Showing results 21-40

All JobsQuality Engineer Software Validation JobsQuality Engineer Software Validation Jobs in Illinois

Quality Engineer Software Validation information

What cities in Illinois are hiring for Quality Engineer Software Validation jobs?

Cities in Illinois with the most Quality Engineer Software Validation job openings:

Infographic showing various Quality Engineer Software Validation job openings in Illinois as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 18% Part Time, 3% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution.

Software Quality Assurance Engineer - III

Lake Forest, IL • On-site

Epitec
Recruiting and Staffing Services • 1 - 5K employees
Learn more about Epitecexternal

$35 - $40/hr

Contractor

Posted 25 days ago

Job description

  • Location: Lake Forest, Illinois
  • Type: Contract
  • Job #106130

Job Title: Software Quality Assurance Engineer III
Contract Duration: 3 months, possible extension
Location: Lake Forest, IL
Work Arrangement: Onsite
Pay Range: $35 - $40 per hour
Summary
The Software Quality Assurance Engineer III will be responsible for ensuring regulatory compliance and quality assurance for healthcare software products. This role focuses on supporting quality system compliance activities, software validation efforts, risk management processes, and regulatory requirements within a highly regulated healthcare environment. The ideal candidate will work independently, partner with cross-functional teams across multiple geographic locations, and help ensure that software solutions are compliant, practical, innovative, and aligned with organizational objectives.
This individual may lead quality initiatives and represent the QA function on cross-functional project teams while supporting the ongoing effectiveness of Quality Systems, key processes, and regulatory compliance programs.
Responsibilities
  • Ensure regulatory compliance for healthcare software products and related quality processes.
  • Support and maintain Quality System effectiveness by identifying, addressing, and documenting non-compliance issues.
  • Perform software quality assurance and testing activities within a regulated environment.
  • Create, review, and maintain risk management documentation to evaluate and mitigate product risks.
  • Collaborate with cross-functional teams to ensure product safety, effectiveness, and compliance throughout the development lifecycle.
  • Participate in quality and compliance initiatives that support organizational and regulatory objectives.
  • Provide quality oversight and guidance for software development and validation activities.
  • Contribute to project execution and represent QA on cross-functional teams as needed.

Required Qualifications
  • Bachelors degree in Life Sciences, Engineering, or a closely related discipline; equivalent combination of education and experience may be considered.
  • Minimum 5 years of experience in a Quality Assurance or Quality-related role.
  • Experience performing software testing in a regulated industry environment.
  • Strong understanding of healthcare industry standards, regulations, and regulatory agencies.
  • Demonstrated experience with risk management methodologies and product compliance activities.
  • Ability to work independently and take ownership of assigned responsibilities.
  • Proven ability to collaborate effectively with cross-functional teams across multiple locations.

Required Skills
  • Software Quality Assurance and Testing
  • Regulatory Compliance in Healthcare/Medical Device Environment
  • Quality Systems and Compliance Management
  • Risk Management and Documentation
  • Cross-Functional Team Collaboration
  • Independent Problem Solving and Ownership
  • Product Safety and Effectiveness Evaluation

Preferred Qualifications
  • Knowledge of Software Development Lifecycle (SDLC)
  • Experience with Cloud-Based Software Applications
  • Understanding of Cybersecurity Standards and Requirements
  • Experience supporting regulated healthcare software development projects

Experience
  • 5+ years of Quality Assurance or Quality-related experience within a regulated environment.
  • Experience supporting healthcare, medical device, pharmaceutical, or similarly regulated industries preferred.

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