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Quality Engineer - Validation

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Nemera

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Location:
United States , Buffalo Grove

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Category:

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Contract Type:
Not provided

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Salary:

85000.00 - 105000.00 USD / Year

Job Description:

The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance.

Job Responsibility:

  • Assists the Quality Manager in coordinating and executing objectives
  • Identify and coordinate resolution of system inefficiencies
  • Coordinate and manage the execution of validations and creation of written protocols
  • Coordinate and manage the execution of change control activities
  • Assess results of Customer Complaint investigations and Corrective Actions
  • Utilize CAPA problem solving techniques
  • Develop and analyze statistical data
  • Evaluate compliance using relevant information and individual judgment
  • Develop product specifications for existing products
  • Plan, coordinate, and manage assigned Supplier Quality evaluations
  • Interact with suppliers
  • Support implementation and management of quality agreements with assigned suppliers
  • Plan, promote, perform and organize training activities
  • Interact with customers
  • Assist the Quality Managers during customer audits
  • Assist in maintaining ISO and FDA QSR quality systems compliance
  • Execute specific responsibilities as defined within the company quality operating system
  • Support and maintain all policies of the company
  • Identify and complete continuous improvement projects utilizing Six Sigma tools

Requirements:

  • Bachelor’s degree in Engineering, Science or related field required
  • 3+ years' of experience in a Quality position strongly preferred
  • Experience in the Medical Device industry strongly preferred (ISO13485)
  • Experience with technical writing, IQ/OQ/PQ is preferred
  • Experience with equipment validation is preferred
  • Experience working onsite in Manufacturing is strongly preferred
  • Excellent communication skills with the ability to understand, read, write and speak English required
  • Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
  • Six-sigma experience, training or certification preferred
  • Intermediate level computer skills, including Microsoft Office applications required
  • SAP experience preferred
  • Ability to work independently from verbal and/or written instructions required
  • Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives

Nice to have:

  • Six-sigma experience, training or certification
  • SAP experience

Additional Information:

Job Posted:
January 08, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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