CAPA Quality Engineer & Process Improver

Hologic, Inc.; 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, QA operations, and overall quality systems. You will partner with QMS leadership and cross-functional teams to enhance CAPA performance, remediation efforts, and training.

The ideal candidate has 3–8 years in medical device/IVD/pharma QA with CAPA, root cause analysis, and quality metrics expertise, and will support audits, continuous improvement, and data-driven quality initiatives.

Qualifications

• Bachelor’s degree or higher in a technical field.
• 3–8 years of QA and CAPA experience in medical device/IVD/pharma.
• Experience with FDA, QMS, ISO 13485 compliance.

Responsibilities

• CAPA System Leadership: act as SME for CAPA, review effectiveness checks, and implement corrective actions.
• Quality Assurance Operations: develop, implement, and maintain QA procedures and documentation; identify CAPA improvements.
• Audit and Compliance: support internal/external audits including FDA inspections; ensure readiness and efficiency.

Skills

CAPA expertise

Root cause analysis

QMS ISO13485

Data analysis

Cross-functional collaboration

Executive updates

Education

Technical Bachelor's degree or higher

Tools

Agile PLM

Job description

Hologic is seeking a Quality Engineer, CAPA Facilitator to strengthen CAPA processes, QA operations, and overall quality systems. You will partner with QMS leadership and cross-functional teams to enhance CAPA performance, remediation efforts, and training.

The ideal candidate has 3–8 years in medical device/IVD/pharma QA with CAPA, root cause analysis, and quality metrics expertise, and will support audits, continuous improvement, and data-driven quality initiatives.