Senior Product Quality Engineer - Medical Devices

DIRECT SALES, US; Newark (DE); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic in Newark, Delaware, is seeking a Product Quality Engineer to protect patient safety and drive product excellence for on-market medical devices. You will investigate complaints, conduct risk assessments, and lead CAPA actions across Engineering, Manufacturing, Regulatory, and Quality to ensure continuous improvement.

Collaborate with teams to analyze data, implement corrective actions, and support audits and regulatory inspections while influencing design controls and risk management

Qualifications

• Familiarity with FDA Quality System Regulations (QSR) and risk management.
• Knowledge of ISO 13485 and medical device regulations (EU MDR) is preferred.
• Ability to lead root cause analyses and CAPA actions with cross-functional teams.

Responsibilities

• Lead complaint prioritization and investigations based on product risk and data trends.
• Coordinate cross-functional teams to resolve quality issues.
• Perform health risk assessments for on-market devices.
• Determine corrective and preventive actions and implement improvements.
• Present findings to leadership and ensure regulatory compliance.

Skills

FDA QSR knowledge

ISO 13485

Risk management

Root cause analysis

CAPA leadership

Cross-functional collaboration

Data-driven decision making

Excellent communication

Job description

Hologic in Newark, Delaware, is seeking a Product Quality Engineer to protect patient safety and drive product excellence for on-market medical devices. You will investigate complaints, conduct risk assessments, and lead CAPA actions across Engineering, Manufacturing, Regulatory, and Quality to ensure continuous improvement.

Collaborate with teams to analyze data, implement corrective actions, and support audits and regulatory inspections while influencing design controls and risk management