Lead Post-Market Surveillance & Trend Analytics

Hologic, Inc.; Town of Newark (WI); On-site; USD 116,000 - 182,000; Full time

Job summary

Hologic, Inc. is seeking a Lead Post Market Surveillance Specialist to own complaint trending and post-market analytics. You will define methodologies, governance, and thresholds to detect adverse product quality signals across the product portfolio.

The role requires leading teams or individuals, collaborating with Regulatory Affairs, Quality, and Design Assurance to drive continuous improvement and risk reduction. Strong statistical skills and BI tooling are essential for success.

Qualifications

• Bachelor's degree required in Engineering, Statistics, Mathematics, Data Analytics, Quality, Life Sciences, or related technical discipline.
• 8+ years of experience in medical device, healthcare, life sciences, or regulated industry.
• Experience leading complaint trending, surveillance analytics, quality data analysis, or signal detection processes.
• Experience establishing or improving statistical methodologies, surveillance systems, or quality analytics programs.
• Experience with Power BI, SQL, Minitab, Tableau, or similar analytical tools.

Responsibilities

• Owns the statistical methodologies, normalization approaches, signal detection criteria, escalation thresholds, and decision rules used to identify adverse trends and emerging product quality signals.
• Develops, validates, and improves scientifically sound approaches for complaint trending and signal evaluation.
• Evaluates and implements enhanced surveillance approaches including alert limits and predictive monitoring.
• Leads identification, prioritization, and remediation of gaps in complaint trending processes and analytics capabilities.
• Provides technical leadership, mentoring, and consultation on trending methodologies and surveillance governance.

Skills

Power BI

SQL

Data analysis

Quality systems

Education

Bachelor's degree in Engineering/Statistics/Data Analytics

Tools

Power BI

SQL

Job description

Hologic, Inc. is seeking a Lead Post Market Surveillance Specialist to own complaint trending and post-market analytics. You will define methodologies, governance, and thresholds to detect adverse product quality signals across the product portfolio.

The role requires leading teams or individuals, collaborating with Regulatory Affairs, Quality, and Design Assurance to drive continuous improvement and risk reduction. Strong statistical skills and BI tooling are essential for success.