Senior Post-Market Quality Engineer — PMQA Leader

Hologic; Town of Newark (WI); On-site; USD 138,000 - 230,000; Full time

Job summary

Hologic is seeking a Principal Post Market Quality Engineer to act as the senior technical authority for PMQA, guiding post-market processes across Breast & Skeletal Health Solutions to ensure patient safety and regulatory compliance. The role involves risk-based decisions, data analysis, and cross-functional leadership to continuously improve the quality system.

The candidate will lead investigations, health risk assessments, and post-market data trending, while coordinating with design,

Qualifications

• Experience in medical device PMQA and post-market processes.
• Ability to make risk-based decisions under regulatory scrutiny.
• Experience supporting FDA inspections and CAPAs is preferred.

Responsibilities

• Serve as senior technical authority across PMQA processes.
• Lead investigations, trend data, and risk assessments.
• Develop and govern procedures, templates, and documentation.
• Coach engineers and process leads; collaborate with cross-functional teams.
• Represent PMQA during inspections and regulatory activities.

Skills

Technical leadership

Post Market QA

Regulatory knowledge

Data analysis

Risk assessment

Investigation leadership

Cross-functional collaboration

Training/coaching

Education

Bachelor’s Degree in Engineering

Advanced degree preferred

Tools

Salesforce-based complaint systems

Agile / electronic QMS

Design of experiments

Reliability analysis

Job description

Hologic is seeking a Principal Post Market Quality Engineer to act as the senior technical authority for PMQA, guiding post-market processes across Breast & Skeletal Health Solutions to ensure patient safety and regulatory compliance. The role involves risk-based decisions, data analysis, and cross-functional leadership to continuously improve the quality system.

The candidate will lead investigations, health risk assessments, and post-market data trending, while coordinating with design,