Senior Post-Market Quality Engineer & Technical Lead

Hologic, Inc.; Newark, Northern (DE, KY); Hybrid; USD 138,000 - 230,000; Full time

Job summary

Hologic, Inc. in Newark, DE is seeking a Principal Post Market Quality Engineer to serve as the senior technical authority for Post Market Quality Assurance.

You will lead risk-based post-market processes to ensure patient safety and regulatory compliance across Breast & Skeletal Health Solutions product lines. The role requires deep knowledge of PMQA, complaint handling, medical device reporting, and data analysis, with the ability to mentor teams and represent PMQA during inspections.

Qualifications

• Bachelor’s Degree in Engineering required; Mechanical, Electrical, Biomedical, or BIomechanical preferred.
• Advanced degree preferred.
• Minimum 8 years of direct Post Market experience in medical device quality.

Responsibilities

• Lead PMQA processes, investigations, CAPA, and post-market data analysis.
• Support regulatory inspections and readiness activities during audits.
• Coach and mentor engineers and process leads across product lines.

Skills

Senior technical authority

Risk-based decision making

Technical leadership

Mentoring engineers

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Advanced degree preferred

PhD preferred

Tools

Salesforce

Quality Management Software

Statistical software

Job description

Hologic, Inc. in Newark, DE is seeking a Principal Post Market Quality Engineer to serve as the senior technical authority for Post Market Quality Assurance.

You will lead risk-based post-market processes to ensure patient safety and regulatory compliance across Breast & Skeletal Health Solutions product lines. The role requires deep knowledge of PMQA, complaint handling, medical device reporting, and data analysis, with the ability to mentor teams and represent PMQA during inspections.