Senior Product Quality Engineer - Medical Devices

Hologic, Inc.; Newark (DE); On-site; USD 85,300 - 133,000; Full time

Job summary

Hologic, Inc. in Newark, Delaware seeks a Product Quality Engineer to impact patient safety and product excellence.

You will investigate performance issues, conduct risk assessments, and drive CAPAs across Quality, Manufacturing, and Engineering teams to enhance product quality and reliability. You will lead cross-functional efforts from root-cause analysis to corrective actions, ensuring compliance throughout the product lifecycle and delivering high‑quality medical devices that improve patient

Qualifications

• Experience with FDA QSR, ISO 13485, and risk management.
• Ability to lead cross-functional teams on CAPAs and investigations.
• Strong communication and presentation skills.

Responsibilities

• Lead complaint prioritization and investigations based on product risk and data trends.
• Coordinate cross-functional teams to drive timely resolution of quality issues.
• Perform health risk assessments for on-market medical devices.
• Determine CAPAs with Quality, Operations, Engineering, R&D, Regulatory, and Manufacturing teams.
• Analyze and trend data to identify emerging risks and present findings to leadership.
• Manage design and process change projects, including testing and change control.
• Develop and enhance investigation and testing methods for problem-solving.

Skills

FDA QSR

Design Control

ISO 13485

EU MDR

Risk Management

GMP

GDP

Leadership

Communication

Job description

Hologic, Inc. in Newark, Delaware seeks a Product Quality Engineer to impact patient safety and product excellence.

You will investigate performance issues, conduct risk assessments, and drive CAPAs across Quality, Manufacturing, and Engineering teams to enhance product quality and reliability. You will lead cross-functional efforts from root-cause analysis to corrective actions, ensuring compliance throughout the product lifecycle and delivering high‑quality medical devices that improve patient