Vacancy Description
Distribution Quality Assurance Specialist
Newark, DE, United States
The Distribution Quality Assurance Specialist at Hologic is responsible for ensuring the quality and compliance of distribution processes, particularly through the assessment, qualification, and ongoing management of Distribution Service Providers (DSPs) such as 3PLs, Logistic Service Providers, and Distributors.
The role focuses on maintaining product integrity throughout distribution channels, supporting continuous improvement, and ensuring alignment with U.S. FDA regulations, ISO standards, and internal quality system requirements. The position requires collaboration with various departments, oversight of compliance documentation, and active participation in audits, risk management, and corrective actions.
**Knowledge**
+ Proficient understanding of U.S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systems
+ Experience in root cause ...
Newark, DE, United States
The Distribution Quality Assurance Specialist at Hologic is responsible for ensuring the quality and compliance of distribution processes, particularly through the assessment, qualification, and ongoing management of Distribution Service Providers (DSPs) such as 3PLs, Logistic Service Providers, and Distributors.
The role focuses on maintaining product integrity throughout distribution channels, supporting continuous improvement, and ensuring alignment with U.S. FDA regulations, ISO standards, and internal quality system requirements. The position requires collaboration with various departments, oversight of compliance documentation, and active participation in audits, risk management, and corrective actions.
**Knowledge**
+ Proficient understanding of U.S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systems
+ Experience in root cause ...
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