Senior Medical Devices Quality Engineer — Impact & Compliance

Hologic, Inc.; Marlborough (MA); Hybrid; USD 98,000 - 135,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA seeks a Sr. Product Quality Engineer to provide engineering support for on-market medical devices.

You will lead complaint investigations, perform root cause analyses, and implement CAPA to enhance product quality and compliance. Collaborate across functions to drive improvements, risk management, and patient safety. The role entails mentoring junior engineers and ensuring processes align with FDA QSR, ISO 13485, and EU MDR requirements.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) is required.
• 5+ years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry.
• Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
• Familiarity with internal and external audits, including Notified Body and FDA inspections.

Responsibilities

• Lead complaint investigations and root cause analyses to resolve quality issues.
• Implement corrective and preventive actions to improve product quality and compliance.
• Collaborate with cross-functional teams to drive process improvements and risk management.

Skills

Complaint investigations

Root cause analysis

CAPA

Data analysis

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering

Job description

Hologic, Inc. in Marlborough, MA seeks a Sr. Product Quality Engineer to provide engineering support for on-market medical devices.

You will lead complaint investigations, perform root cause analyses, and implement CAPA to enhance product quality and compliance. Collaborate across functions to drive improvements, risk management, and patient safety. The role entails mentoring junior engineers and ensuring processes align with FDA QSR, ISO 13485, and EU MDR requirements.