Quality Specialist – Product Complaint Investigation and Analysis

Quality Specialist – Product Complaint Investigation and Analysis

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 independently handle all aspects ofpost-market complaints under the guidance of product subject matter experts and quality leadership, from intake of complaints from customer service teams to complaint monitoring / trending and root cause investigation. The QA Specialist monitors and analyzes complaint data for adverse trends.

The QA Specialist then works hands-on in laboratory with Hologic’s molecular diagnostic products to investigate safety impact and root cause of these trends. This role facilitates the documentation of activities throughout the complaint handling process incompliance with applicable industry regulations, standards, and company policy.

• Complaint Handling, receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
• Ensure timely, accurate, and complete complaint records in the complaint management system
• Plan and execute testing and / or inspection of Hologic molecular diagnostic products
• Analyze testing data/product information to assess and document complaint risk in accordance with ISO
  14971 and QMS requirements
• Collect, analyze, and / or present test results or other data in cross-functional presentations, reports, or quality system documentation
• Support management of equipment, inventory, product testing in the Quality Technical Investigation laboratory as needed
• Regulatory Reporting
• Identify and elevate 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, contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance

• 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…