Quality Specialist - Product Complaints

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). 

• →Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity  

• →Ensure timely, accurate, and complete complaint records in the complaint management system 

• →May support product complaint investigations, including lab testing, risk assessment, and root cause analysis as needed. 

• →Regulatory Reporting: 

• →Identify and escalate potential adverse events to QA management. 

• →Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements  

• →Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards 

• →Data Analysis & Trending: 

• →Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues  

• →Audit & Inspection Support: 

• →Support internal and external audits related to post-market surveillance and complaint handling as needed 

• →Maintain accurate and audit-ready documentation. 

• →Training & Process Development: 

• Quality Systems:  Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance  / CAPA processes 

• Compliance:  Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements 

• Data Trending:  Basic knowledge of tracking and trending product / process metrics and KPI’s with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high volume products 

• Product Knowledge:  Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems 

• Communication: aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports 

• Organization: skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting 

• Data Analysis: aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions 

• Detail Oriented: proactively identifies and focuses on critical details needed to ensure accurate and high-quality results 

• Inquisitive: strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others 

• Quality / Safety Focused: committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts 

• Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change 

• B.S. in scientific or engineering discipline