Post Market Quality Specialist 3

Hologic • Newark, NJ

1d

About The Position

Job Summary: The Sr. Post Market Quality Specialist performs statistical analysis of complaint and post market data for assigned Hologic product families, identifying trends, emerging signals, and opportunities for quality improvement. The Specialist owns and leads the Post Market Surveillance Review Boards (PMS RBs), presenting product performance metrics, trend summaries, and identified signals requiring follow up. Working in close partnership with Product Quality Engineers (PQEs), the Specialist supports moderate complaint investigations by providing high quality data analysis, code review, and early signal assessment to inform cross functional decisions. The role maintains and reconciles PMS datasets, contributes complaint data for required PMS documentation, and serves as the primary point of contact for complaint related analytics. 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 & Post Market Data Analysis Perform routine and ad hoc analysis of complaint and post market data for assigned product families Identify trends, anomalies, and early warning signals using statistical methods and established KPIs Extract and validate complaint data to support PQEs, QDEs, and cross functional investigation teams Conduct “as reported vs. as analyzed” complaint code reconciliation to ensure accurate surveillance insights PMS Review Boards (PMSRBs) Own, schedule, prepare, and present BU level Post Market Surveillance Review Boards Summarize key complaint trends, signals, KPIs, and actions required for follow up Ensure PMS RB records are accurately documented and released in PLM in a timely manner Investigation Support Support product investigations in partnership with PQEs and QDEs, providing data analysis, trending support, and preliminary signal assessment Provide rapid complaint data inputs for emerging issues, field escalations, and early investigations Perform queries and generate trend analyses for CAPA inputs, Health Risk Assessments (HRAs), and cross functional assessments PMS Documentation & Reporting Supply complaint data for PMS Plans, PMS Reports, PSURs, and Canadian Summary Reports, as requested Provide complaint data to support PMCF and Clinical Evaluation documentation Maintain surveillance trackers, templates, and other PMS documentation tools to ensure accuracy, consistency, and compliance Compile and report weekly and monthly surveillance metrics and KPIs to support Quality leadership Cross Functional Collaboration Partner closely with PQEs, Product Support, QDEs, and other key functions to ensure consistent complaint coding, accurate data interpretation, and alignment on findings Support cross functional discussions on product performance, emerging risks, and needed follow up actions Continuous Improvement & Data Quality Recommend and implement improvements to complaint coding, data quality, PMS processes, and analytical workflows Support alignment of divisional PMS processes with corporate standards and data governance expectations Contribute to internal and external audits/inspections by providing accurate complaint data and documentation support

Requirements

• Bachelor’s degree in Engineering, Science, or related technical field
• 5+ years in post market quality, complaint handling, quality engineering, or similar analytical role.
• Medical device experience preferred
• Strong analytical and statistical skills; experience identifying trends and early warning signals
• Working knowledge of FDA 21 CFR 820.198, ISO 13485, ISO 14971, and EU MDR PMS requirements
• Strong communication skills for presenting data to cross functional teams and leadership
• Effective organization, prioritization, and problem solving skills
• Computer skills: Microsoft Office, Minitab, Oracle, Agile and Salesforce

Responsibilities

• Perform routine and ad hoc analysis of complaint and post market data for assigned product families
• Identify trends, anomalies, and early warning signals using statistical methods and established KPIs
• Extract and validate complaint data to support PQEs, QDEs, and cross functional investigation teams
• Conduct “as reported vs. as analyzed” complaint code reconciliation to ensure accurate surveillance insights
• Own, schedule, prepare, and present BU level Post Market Surveillance Review Boards
• Summarize key complaint trends, signals, KPIs, and actions required for follow up
• Ensure PMS RB records are accurately documented and released in PLM in a timely manner
• Support product investigations in partnership with PQEs and QDEs, providing data analysis, trending support, and preliminary signal assessment
• Provide rapid complaint data inputs for emerging issues, field escalations, and early investigations
• Perform queries and generate trend analyses for CAPA inputs, Health Risk Assessments (HRAs), and cross functional assessments
• Supply complaint data for PMS Plans, PMS Reports, PSURs, and Canadian Summary Reports, as requested
• Provide complaint data to support PMCF and Clinical Evaluation documentation
• Maintain surveillance trackers, templates, and other PMS documentation tools to ensure accuracy, consistency, and compliance
• Compile and report weekly and monthly surveillance metrics and KPIs to support Quality leadership
• Partner closely with PQEs, Product Support, QDEs, and other key functions to ensure consistent complaint coding, accurate data interpretation, and alignment on findings
• Support cross functional discussions on product performance, emerging risks, and needed follow up actions
• Recommend and implement improvements to complaint coding, data quality, PMS processes, and analytical workflows
• Support alignment of divisional PMS processes with corporate standards and data governance expectations
• Contribute to internal and external audits/inspections by providing accurate complaint data and documentation support

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees