CAPA Facilitator & Quality Assurance Associate

DIRECT SALES, US; Newark (DE); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic is hiring a CAPA Facilitator Associate to support a broad range of quality system activities. You will use data and cross-functional collaboration to investigate issues, document outcomes, and contribute to continuous improvement across the division.

This is a career-level role for an experienced professional who can work independently, exercise sound judgment, and resolve quality-related issues in a practical way. The base salary is competitive and bonus eligible.

Qualifications

• Experience in quality assurance and CAPA within regulated environments.
• Experience supporting CAPA processes, root cause analysis and effectiveness checks.
• Understanding of audit preparation and support activities.

Responsibilities

• Support quality values and quality system requirements across the division.
• Collaborate with cross-functional teams and stakeholders.
• Coordinate quality activities and support QA department leadership.
• Facilitate CAPA processes including corrective and preventive actions.
• Provide guidance on root cause evaluation and CAPA effectiveness.
• Review CAPA system daily and coordinate with departments for resources.
• Maintain divisional CAPA toolbox, training materials and documents.
• Prepare documentation from site CAPA Review Board meetings.
• Serve as a point of contact for CAPA and training content.
• Support audits and regulatory inspections and improve audit efficiency.

Skills

Quality Assurance

CAPA processes

Root cause analysis

Audits

Quality metrics

Cross-functional collaboration

Communication

Procedures

KPIs

Data analysis

Education

Technical Bachelor's degree

Bachelor's degree in related field

Tools

Agile PLM

Job description

Hologic is hiring a CAPA Facilitator Associate to support a broad range of quality system activities. You will use data and cross-functional collaboration to investigate issues, document outcomes, and contribute to continuous improvement across the division.

This is a career-level role for an experienced professional who can work independently, exercise sound judgment, and resolve quality-related issues in a practical way. The base salary is competitive and bonus eligible.