CAPA Quality Engineer & Process Improvement Lead

Socket.dev; Newark (DE); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic is seeking a Quality Engineer, CAPA Facilitator to strengthen CAPA processes and broader QA operations. You will partner with QMS leadership to improve CAPA performance, support remediation, and sustain compliant quality systems.

The role requires CAPA expertise in regulated environments (medical devices/pharma), strong root cause analysis, data-driven decision making, and collaboration across cross-functional teams.

Qualifications

• 3–8 years of experience in medical device, IVD, or pharmaceutical QA and CAPA systems.
• Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.
• Strong working knowledge of QMSR, ISO 13485, and global quality regulations.
• Excellent technical writing, analytical, and problem-solving skills.

Responsibilities

• Serve as an expert for CAPA, including root cause analysis and effective corrective actions.
• Coordinate CAPA Review Board meetings and related documentation.
• Own and improve the CAPA toolbox, including training materials.
• Monitor CAPA system health and coordinate with departments for resourcing.
• Provide input into global CAPA process improvements and training content.
• Support quality assurance procedures, processes, and documentation.

Skills

CAPA expertise

Root cause analysis

Quality metrics

Audit support

Continuous improvement

QMSR familiarity

ISO 13485 knowledge

Cross-functional leadership

Technical writing

Statistics

Education

Technical Bachelor’s degree or higher

Tools

Agile/PLM

Job description

Hologic is seeking a Quality Engineer, CAPA Facilitator to strengthen CAPA processes and broader QA operations. You will partner with QMS leadership to improve CAPA performance, support remediation, and sustain compliant quality systems.

The role requires CAPA expertise in regulated environments (medical devices/pharma), strong root cause analysis, data-driven decision making, and collaboration across cross-functional teams.