Distribution Quality Assurance Specialist
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Before you apply
Salary$66k – $103k
LocationNewark, DE, United States
Typefull-time
SeniorityMid
Experience3+ yrs
DepartmentQuality Assurance
Company size10,000+ people
First seenOct 18, 2026 · 2w ago
Verified live2d ago
At a glanceSummarised by Seekless from the posting.
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
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
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
Knowledge of Power BI and AI tools is a plus
Advanced degree is a plus
Experience with logistics and distribution processes is highly preferred
Agency and Third-Party Recruiter Notice: Agencies that submit a resume must have a current executed Hologic Agency Agreement and be invited by a Hologic Recruiter
Equal Opportunity Employer inclusive of disability and veterans
Skills
Microsoft Office
Power BI
AI tools
PLM
ERP
Benefits
Training
About the role
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.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.