Product Quality Investigator II — Root Cause & CAPA Lead

Hologic, Inc.; Newark (DE); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. is seeking a Quality Engineer to lead investigations into product complaints, perform root cause analysis, and drive CAPA implementation. You will partner with cross-functional teams to assess risk, develop improvement plans, and coordinate change controls.

This role requires FDA quality systems knowledge and strong communication skills. The position emphasizes field and internal investigations, data analysis, and presenting findings to leadership.

Qualifications

• Knowledge of FDA Quality System Regulations and ISO 13485.
• Strong root cause analysis and problem-solving skills.
• Excellent communication and presentation abilities.
• Experience leading cross-functional teams.

Responsibilities

• Provide input in prioritization of complaints based on risk, data, and strategic impact.
• Own investigations and root cause analysis, coordinating with stakeholders.
• Collaborate with cross-functional teams, determine CAPA requirements and scope changes.
• Execute Health Risk Assessments and coordinate with internal teams.

Job description

Hologic, Inc. is seeking a Quality Engineer to lead investigations into product complaints, perform root cause analysis, and drive CAPA implementation. You will partner with cross-functional teams to assess risk, develop improvement plans, and coordinate change controls.

This role requires FDA quality systems knowledge and strong communication skills. The position emphasizes field and internal investigations, data analysis, and presenting findings to leadership.