Location
San Diego
Job Type
Full-time
Posted
July 08, 2026
Job Description
Quality Assurance SpecialistAbout the Role
We are seeking a Quality Assurance Specialist to join a growing team within an ISO 13485-regulated In Vitro Diagnostics (IVD) manufacturing environment. This role is ideal for a quality professional who excels at documentation review, compliance oversight, and supporting the release of high-quality products that meet regulatory standards.
As a key member of the Quality team, you will provide quality oversight for manufacturing operations, ensuring batch records and supporting documentation are accurate, complete, and compliant prior to product release. You'll collaborate cross-functionally with Manufacturing, Quality Control, and Regulatory teams to maintain quality system effectiveness and drive continuous improvement.
Key Responsibilities
+ Review batch records and manufacturing documentation for accuracy, completeness, and compliance prior to product release.
+ Perform review of QC records, raw material inspection...
We are seeking a Quality Assurance Specialist to join a growing team within an ISO 13485-regulated In Vitro Diagnostics (IVD) manufacturing environment. This role is ideal for a quality professional who excels at documentation review, compliance oversight, and supporting the release of high-quality products that meet regulatory standards.
As a key member of the Quality team, you will provide quality oversight for manufacturing operations, ensuring batch records and supporting documentation are accurate, complete, and compliant prior to product release. You'll collaborate cross-functionally with Manufacturing, Quality Control, and Regulatory teams to maintain quality system effectiveness and drive continuous improvement.
Key Responsibilities
+ Review batch records and manufacturing documentation for accuracy, completeness, and compliance prior to product release.
+ Perform review of QC records, raw material inspection...