Distribution Quality Assurance Specialist
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
Nice To Haves
- Advanced degree is a plus
- Knowledge of Power BI and AI tools is a plus
- Experience with logistics and distribution processes is highly preferred
Responsibilities
- Assessment, qualification, and ongoing management of Distribution Service Providers (DSPs)
- Maintaining product integrity throughout distribution channels
- Supporting continuous improvement
- 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
Benefits
- Comprehensive training when you join
- Continued development and training throughout your career
- Bonus eligible
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
