Quality Assurance Specialist

Distribution Quality Assurance SpecialistThe 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.KnowledgeProficient understanding of U.S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systemsExperience in root cause analysis, risk assessment, CAPA (Corrective and Preventive Actions), and auditingKnowledge of logistics and distribution processesFamiliarity with PLM and ERP systemsComputer literacy, including Microsoft Office; knowledge of Power BI and AI tools is a plusSkillsStrong analytical and problem-solving abilitiesAbility to produce reports and define action plansExcellent interpersonal and cross-functional communication skillsNegotiation and persuasion skillsAdaptability to changing environmentsAbility to work independently and collaborativelyProactive and organized, with the capacity to manage multiple priorities and meet deadlinesBehaviorDemonstrates ownership and accountabilityActs with integrity and a quality mindsetDrives continuous improvementMaintains a customer-focused approachWorks effectively both individually and in teamsExperienceBachelor'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 functionExperience supporting FDA inspections and internal/external auditsExperience with logistics and distribution processes is highly preferredWe 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.