Quality Specialist - Product Complaints

Hologic, Inc. · San Diego, California, United States

Location
San Diego
Job Type
Full-time
Posted
July 08, 2026

Job Description

The Post-Market QA Specialist plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

  •  Complaint Handling and Investigation: 
  • Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR). 
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