Distribution QA Lead: Compliance & Logistics

Hologic, Inc.; Newark (DE); On-site; USD 65,900 - 103,000; Full time

Job summary

Hologic, Inc. is seeking a Distribution Quality Assurance Specialist to ensure the quality and compliance of distribution processes, including management of Distribution Service Providers (DSPs) such as 3PLs, logistic providers, and distributors.

The role focuses on maintaining product integrity across distribution channels, supporting continuous improvement and ensuring alignment with U.S. FDA regulations, ISO standards, and internal quality systems.

Qualifications

• : Bachelor’s degree in Engineering, Quality Assurance, Supply Chain, Logistics, or related field.
• : Minimum of 3 years’ experience in medical device manufacturing or related industry, preferably in Quality.
• : Experience supporting FDA inspections and audits.

Responsibilities

• Ensure quality and compliance of distribution processes.
• Assess, qualify, and manage Distribution Service Providers.
• Support audits, risk management, and corrective actions.

Skills

Analytical skills

Problem solving

Reporting

Cross-functional communication

Negotiation

Adaptability

Independent and collaborative work

Education

Bachelor’s Degree in Engineering or related field

Tools

PLM

ERP

Power BI

Job description

Hologic, Inc. is seeking a Distribution Quality Assurance Specialist to ensure the quality and compliance of distribution processes, including management of Distribution Service Providers (DSPs) such as 3PLs, logistic providers, and distributors.

The role focuses on maintaining product integrity across distribution channels, supporting continuous improvement and ensuring alignment with U.S. FDA regulations, ISO standards, and internal quality systems.