Senior QA Engineer - Product Quality (Medical Devices)

Hologic; Louisville (KY); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. is seeking a Quality Assurance Engineer 3 to lead the product quality program, including holds, stop ships, and field actions. You will develop QMS procedures, work with cross-functional teams, and drive improvements to ensure regulatory compliance and robust product quality.

The role emphasizes strong investigations, root-cause analysis, and training across teams to sustain continuous quality improvements in a fast-paced, regulated medical-device environment.

Qualifications

• 2-4 years in QA or related roles in a regulated medical device environment.
• Hands-on with field actions, holds, and stop ships processes.
• Experience supporting QMS initiatives and process improvements.
• Experience conducting root cause investigations and corrective actions.
• Cross-functional collaboration on quality improvement projects.

Responsibilities

• Manage product holds, stop ships, corrections, and field actions.
• Develop and maintain QMS procedures and work instructions.
• Collaborate with cross-functional teams to ensure compliance and efficiency.
• Document progress, track closure of records, and generate training materials.
• Provide guidance and training to ensure proper use of quality tools and systems.

Skills

QMS development

Field actions management

Regulatory knowledge

Root cause analysis

Cross-functional liaison

Technical writing

Training & support

Job description

Hologic, Inc. is seeking a Quality Assurance Engineer 3 to lead the product quality program, including holds, stop ships, and field actions. You will develop QMS procedures, work with cross-functional teams, and drive improvements to ensure regulatory compliance and robust product quality.

The role emphasizes strong investigations, root-cause analysis, and training across teams to sustain continuous quality improvements in a fast-paced, regulated medical-device environment.