CAPA Facilitator & Quality Systems Lead

DIRECT SALES, US; Newark (DE); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic seeks a Quality Engineer, CAPA Facilitator to strengthen CAPA and QA operations across the organization. You will partner with QMS leadership to drive CAPA performance, remediation, and training, while sustaining robust quality systems.

The role requires experience in regulated environments (medical devices, IVD, or pharma), CAPA, root cause analysis, data-driven improvement, and cross-functional collaboration. You will support audits, metrics, and continuous improvement initiatives.

Qualifications

• Experience in medical device/IVD/pharma QA with CAPA systems.
• Strong CAPA/root-cause analysis, metrics, and trend analysis.
• Experience supporting FDA inspections and audits.
• Proven ability to train and mentor staff.

Responsibilities

• Lead CAPA system activities and root cause analysis.
• Facilitate CAPA Review Board meetings and document control.
• Improve CAPA tools, templates, and training resources.
• Monitor CAPA health, escalate risks, and coordinate resources.
• Develop quality metrics, dashboards, and reporting.

Skills

CAPA management

root cause

data analysis

audits

QMS ISO13485

cross-functional

documentation

training

statistics

regulatory compliance

Education

Technical Bachelor's degree

Tools

Agile PLM

Job description

Hologic seeks a Quality Engineer, CAPA Facilitator to strengthen CAPA and QA operations across the organization. You will partner with QMS leadership to drive CAPA performance, remediation, and training, while sustaining robust quality systems.

The role requires experience in regulated environments (medical devices, IVD, or pharma), CAPA, root cause analysis, data-driven improvement, and cross-functional collaboration. You will support audits, metrics, and continuous improvement initiatives.