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Quality Engineer

Company

Karwell Technologies

Location

Chicago, Illinois, United States

Type

Full-time

Job Description:

The Quality Engineer provides cross-divisional support for remediation efforts and is responsible for independently establishing and maintaining quality standards across a portfolio that includes medical devices, commodities, OTC drugs, and cosmetic products. The role involves evaluating production processes, recommending improvements, managing suppliers, and ensuring compliance with regulatory requirements through proper documentation and quality systems.

Roles & Responsibilities:

  • Provide quality expertise in Product Development, Design Control, Design History Files (DHF), CAPA, Risk Management, and CE Technical Files.

  • Collaborate with suppliers to resolve quality issues, implement corrective actions (CAPA, SCAR), and lead supplier qualification activities.

  • Investigate product and process non-conformances, out-of-specification results, and implement ...

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