Distribution QA & Compliance Specialist

DIRECT SALES, US; Newark (DE); On-site; USD 66,000 - 103,000; Full time

Job summary

Hologic, Inc. is seeking a Distribution Quality Assurance Specialist to ensure quality and compliance across distribution channels, including DSPs, 3PLs, and distributors. You will oversee audits, risk management, CAPAs, and regulatory alignment with FDA requirements and ISO standards.

The role emphasizes collaboration across departments, maintaining documentation, and driving continuous improvement while supporting product integrity in distribution networks.

Qualifications

• Requires a Bachelor’s degree in Engineering, Quality Assurance, Supply Chain, Logistics, or related field (advanced degree a plus).
• Minimum 3 years’ experience in medical device manufacturing or related field, preferably in Quality.
• Experience supporting FDA inspections and audits is preferred.

Responsibilities

• Ensure quality and compliance of distribution processes throughout DSPs, 3PLs, and distributors.
• Support audits, risk management, investigations, and CAPA activities.
• Maintain adherence to FDA regulations, ISO standards, and internal quality systems.
• Collaborate across departments to manage distribution documentation and improvements.

Skills

Analytical thinking

Report writing

Cross-functional communication

Negotiation

Adaptability

Independent working

Time management

Education

Bachelor’s degree in Engineering/QA/Logistics

Advanced degree preferred

Tools

Power BI

ERP systems

PLM

Microsoft Office

Job description

Hologic, Inc. is seeking a Distribution Quality Assurance Specialist to ensure quality and compliance across distribution channels, including DSPs, 3PLs, and distributors. You will oversee audits, risk management, CAPAs, and regulatory alignment with FDA requirements and ISO standards.

The role emphasizes collaboration across departments, maintaining documentation, and driving continuous improvement while supporting product integrity in distribution networks.