Senior Post-Market Quality Engineer (PMQA)

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

Job summary

Hologic, Inc. is seeking a Principal Post Market Quality Engineer to serve as the senior technical authority for PMQA, leading risk-based post-market processes across Breast & Skeletal Health Solutions to ensure patient safety and regulatory compliance.

You will influence design, manufacturing, CAPA, and field actions while driving quality system remediation and data-driven improvements across product lines. Strong regulatory knowledge and leadership without direct authority are essential.

Qualifications

• Bachelor’s Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical preferred.

Responsibilities

• Acts as senior technical authority across PMQA processes.
• Designs, improves, and governs procedures, decision trees, forms, templates, and documentation.
• Leads gap assessments, remediation activities, process improvements, retrospective reviews, and verification of effectiveness.
• Provides technical direction to process leads and cross-functional teams without direct authority.
• Supports complex complaint investigations, root cause analysis, escalation decisions, reportability assessments, CAPA, nonconformance, and field action evaluations.
• Enhances post-market data analysis, trending, and signal detection methods.
• Represents PMQA during inspections and audits, including readiness prep and corrective actions.
• Communicates with executives, regulators, inspectors, technical teams, and cross-functional partners.
• Coaches, mentors, and trains engineers, specialists, and process leads.
• Preferred certifications include ASQ CQE, CRE, or CQA.

Skills

PMQA expertise

Risk-based decisions

Data analysis/trending

Regulatory expectations

Medical device quality

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering

Advanced degree preferred

Tools

Salesforce CRM

Agile QMS systems

Design of experiments

Reliability analysis

Job description

Hologic, Inc. is seeking a Principal Post Market Quality Engineer to serve as the senior technical authority for PMQA, leading risk-based post-market processes across Breast & Skeletal Health Solutions to ensure patient safety and regulatory compliance.

You will influence design, manufacturing, CAPA, and field actions while driving quality system remediation and data-driven improvements across product lines. Strong regulatory knowledge and leadership without direct authority are essential.