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Quality Engineer II

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MillenniumSoft Inc

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Location:
United States , Vernon Hills

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

34.00 - 38.00 USD / Hour
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Job Description:

The Quality Engineer II is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering.

Job Responsibility:

  • Supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering
  • Works cross-functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects and change to win (CTW) projects
  • Work under general direction to exercise judgment within generally defined policies and procedures to select methods and techniques to obtain solutions to problems with broad scope and complexity
  • Work closely with business unit and manufacturing plant management as well as other functions (e.g., Regulatory Affairs, Research and Development, Sustaining Engineering, Manufacturing Quality, Operations, Sterility Assurance, Packaging, Sales, Marketing, Finance etc.)
  • Works cross-functionally with business unit management, as well as their respective teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects and plans

Requirements:

  • Minimum 3 years design controls and risk management experience with medical devices
  • Pharmaceutical knowledge of combination products, preferred
  • Strong knowledge of regulatory requirements (21CFR§4, 21CFR§210&211, 21CFR§820, ISO 13485, CMDR, MDD/EU MDR, and J-PAL)
  • Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)
  • Attentiveness to details with strong organizational and time management skills
  • Excellent verbal and written communication skills and interpersonal skills
  • Ability to work in a team environment
  • Proficiency in Excel, Word, PowerPoint and other desktop/general business systems
  • Position requires a Bachelor of Science degree in Chemistry or Engineering from an accredited four (4) year university

Nice to have:

  • Pharmaceutical knowledge of combination products, preferred
  • Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
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