Product Quality Engineer II: Medical Devices, CAPA & RCA

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

Job summary

Hologic, Inc. is seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. You will lead complaint investigations, perform root cause analyses, and implement CAPA to improve product quality and compliance.

Collaborating with Operations, R&D, and Engineering, you will drive process improvements, assess risks, and deliver solutions that enhance patient safety and customer satisfaction. A strong background in quality engineering is essential.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related) is required.
• 2–5 years of experience in quality engineering, product development, or R&D in an FDA-regulated industry.
• Hands-on experience with complaint investigations, root cause analysis, and CAPA activities.

Responsibilities

• Lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
• Perform root cause analyses and risk assessments to identify mitigations.
• Collaborate with cross-functional teams (Operations, R&D, Engineering) to drive product and process improvements.
• Develop or improve testing methods to support investigations and technical activities.
• Ensure compliance with regulatory standards (FDA QSR, ISO 13485, EU MDR) and quality system requirements.

Skills

Complaint investigations

Root cause analysis

CAPA

Data analysis

Communication skills

Cross-functional collaboration

Verification & Validation

Education

Bachelor’s degree in Engineering

Tools

DOE

Statistical methods

Test method validation

Risk management

Job description

Hologic, Inc. is seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. You will lead complaint investigations, perform root cause analyses, and implement CAPA to improve product quality and compliance.

Collaborating with Operations, R&D, and Engineering, you will drive process improvements, assess risks, and deliver solutions that enhance patient safety and customer satisfaction. A strong background in quality engineering is essential.