Senior Quality Assurance Specialist

1 week ago


Des Plaines, Illinois, United States Collabera Full time
Job Overview

Collabera is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality team, you will be responsible for ensuring the highest standards of quality in our software engineering solutions.

Key Responsibilities:

  • Develop and maintain subject matter expertise in quality processes, including incoming inspection and change management.
  • Support record administration and batch record review, including Certificate of Analysis/Certificate of Conformance creation for material lot release.
  • Assign labeling and pre-production change requests to Change Management staff, ensuring alignment with project load and complexity.
  • Process IUO and IVD product labeling and associated RMS change requests, ensuring compliance with company policies and procedures.
  • Collaborate with cross-functional teams to identify and resolve complex issues.
  • Develop and maintain Design History Files per approved procedures.
  • Review records for good DHF documentation practices and adherence to DHF Document Change Control requirements.

About Collabera

Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.



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