Distribution Quality Assurance 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

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 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; knowledge of Power BI and AI tools is a plus

Skills

• 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

Behavior

• 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

Experience

• Bachelor’s Degree in Engineering, Quality Assurance, Supply Chain Management, Logistics, or a related field (advanced degree is a plus)
• 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

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $65,900-$103,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.