Distribution Quality Assurance Specialist

Hologic•Newark, DE

38d•$65,900 - $103,000

About The Position

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.

Requirements

Proficient understanding of U.S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systems.
Experience in root cause analysis, risk assessment, CAPA (Corrective and Preventive Actions), and auditing.
Knowledge of logistics and distribution processes.
Familiarity with PLM and ERP systems.
Computer literacy, including Microsoft Office.
Bachelor’s Degree in Engineering, Quality Assurance, Supply Chain Management, Logistics, or a related field.
Minimum of 3 years’ experience in medical device manufacturing or a related industry, preferably within a Quality function.
Experience supporting FDA inspections and internal/external audits.
Experience with logistics and distribution processes is highly preferred.
Strong analytical and problem-solving abilities.
Ability to produce reports and define action plans.
Excellent interpersonal and cross-functional communication skills.
Negotiation and persuasion skills.
Adaptability to changing environments.
Ability to work independently and collaboratively.
Proactive and organized, with the capacity to manage multiple priorities and meet deadlines.
Demonstrates ownership and accountability.
Acts with integrity and a quality mindset.
Drives continuous improvement.
Maintains a customer-focused approach.
Works effectively both individually and in teams.

Nice To Haves

Advanced degree is a plus.
Knowledge of Power BI and AI tools is a plus.

Responsibilities

Assessment, qualification, and ongoing management of Distribution Service Providers (DSPs) such as 3PLs, Logistic Service Providers, and Distributors.
Maintaining product integrity throughout distribution channels.
Supporting continuous improvement initiatives.
Ensuring alignment with U.S. FDA regulations, ISO standards, and internal quality system requirements.
Collaboration with various departments.
Oversight of compliance documentation.
Active participation in audits, risk management, and corrective actions.