Distribution Quality Assurance Specialist

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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