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Distribution Quality Assurance Specialist

Hologic Inc

Newark, DE

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JOB DETAILS
SKILLS
Analysis Skills, Artificial Intelligence (AI), Auditing, Code of Federal Regulations, Communication Skills, Computer Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Develop and Maintain Customers, Digital Signal Processing (DSP), Distribution Channel, Distribution Management, Distribution Services, Documentation, ERP (Enterprise Resource Planning), Embedded Software, External Audit, FDA (Food and Drug Administration), FDA Requirements, Healthcare Quality, Human Resources, ISO (International Organization for Standardization), Internal Audit, Interpersonal Skills, Logistics, Logistics Processes, Maintain Compliance, Manufacturing, Medical Equipment, Microsoft Office, Multitasking, Negotiation Skills, Organizational Skills, Persuasion Skills, Power BI, Problem Solving Skills, Process Improvement, Product Engineering, Product Lifecycle Management, Quality Assurance, Quality Engineering, Quality System Requirements (QSR), Radiography, Reporting Skills, Risk Analysis, Risk Management, Root Cause Analysis, Software Administration, Software Design, Software Development, Software Engineering, Supply Chain Management, Systems Engineering, Team Player, Technical Leadership, Third-Party Logistics (3PL), Time Management, Training/Teaching, Women's Health
LOCATION
Newark, DE
POSTED
3 days ago

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Distribution Quality Assurance Specialist

Newark, DE, United States

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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.

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