Quality Engineer - Post-Market Root Cause Analyst

Hologic, Inc.; Newark (DE); On-site; USD 54,900 - 86,000; Full time

Job summary

Hologic, Inc. is seeking a Product Quality Engineer to provide on-market quality engineering support for medical devices. You will perform evaluations, investigations, risk assessments, and root cause analyses in relation to post-market feedback and complaints from the field.

Work with cross-functional teams to implement improvements and corrective actions based on investigation outcomes. The role requires collaboration across departments, data trending, CAPA assessment, and active participation

Qualifications

• Bachelor's degree in engineering is required.
• Experience in FDA-regulated industries is favorable.
• Experience in root cause analysis or product development/R&D is beneficial.

Responsibilities

• Own Investigations and root cause analysis with stakeholders.
• Analyze complaints and data to prioritize investigations by risk and impact.
• Collaborate with cross-functional teams to determine CAPA needs and changes.
• Perform health risk assessments and coordinate with internal teams as needed.
• Support audits and present material to leadership; contribute to change controls.
• Develop testing methods and improve investigation processes.

Skills

FDA QSR

Design Control

Root cause analysis

Data analysis

Communication skills

Risk management

Documentation

Education

Bachelor's Degree in Engineering

Job description

Hologic, Inc. is seeking a Product Quality Engineer to provide on-market quality engineering support for medical devices. You will perform evaluations, investigations, risk assessments, and root cause analyses in relation to post-market feedback and complaints from the field.

Work with cross-functional teams to implement improvements and corrective actions based on investigation outcomes. The role requires collaboration across departments, data trending, CAPA assessment, and active participation