Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Collabera. 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:
- Perform all responsibilities of the Quality Associate, with a focus on subject matter expertise in one or more specific Quality processes.
- 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 the associated RMS change requests, while ensuring compliance with company policies and procedures.
- Assist labeling change owners and junior staff with the creation of design change plans.
- Leverage subject matter expertise to impart positive impacts on organizational outcomes.
- Support change packets per the approved procedures, including analyzing change packets for impact to Device Master Records and for the associated maintenance of the DMRs.
- Independently correct issues and proactively identify future issues.
- Leverage expertise to improve future submissions via collaboration with change owners.
- Create and maintain the Design History Files per the approved procedures.
- Review records for good DHF documentation practices and adherence to the DHF Document Change Control requirements.
- Maintain the Master Action Item List, DHF Index, and the DHF History Index.
- Assist in the documentation of key processes and departmental procedures, and participate in continuous improvement projects as assigned.
- Compile and maintain data used for the creation of department metrics and reports.
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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