Post-Market Quality Engineer I: Root Cause & CAPA

Hologic, Inc.; Newark (DE); On-site; USD 55,000 - 86,000; Full time

Job summary

Hologic, Inc. is seeking a Product Quality Engineer to provide post-market quality engineering support for medical devices. You will own investigations, root cause analysis, risk assessment, and CAPA coordination with cross-functional teams to drive improvements based on complaint data.

The role requires a Bachelor's degree in Engineering and 0–2 years in an FDA-regulated environment. Strong data analysis, documentation, and communication skills are essential, with a focus on maintaining

Qualifications

• Must have a Bachelor’s degree in engineering and 0–2 years of experience in an FDA-regulated environment.
• Experience with root-cause analysis or product development is beneficial.

Responsibilities

• Own investigations and root cause analysis, coordinating with stakeholders.
• Provide input in prioritization of complaints and investigations based on product risk and data.
• Partner with cross-functional teams to determine CAPA requirements and implement changes.
• Perform data analysis and trending of complaints and failure modes to identify mitigations.

Skills

Root cause analysis

FDA QSR

Design Controls

Cross-functional teamwork

Communication skills

Risk management

Statistical methods

Validation

Education

Bachelor's Degree in Engineering

Job description

Hologic, Inc. is seeking a Product Quality Engineer to provide post-market quality engineering support for medical devices. You will own investigations, root cause analysis, risk assessment, and CAPA coordination with cross-functional teams to drive improvements based on complaint data.

The role requires a Bachelor's degree in Engineering and 0–2 years in an FDA-regulated environment. Strong data analysis, documentation, and communication skills are essential, with a focus on maintaining