CAPA & Quality Assurance Facilitator Associate

Hologic, Inc.; Newark (DE); Presencial; USD 78.000 - 122.000; Jornada completa

Descripción de la vacante

Hologic, Inc. currently has two openings for a CAPA Facilitator Associate.

You will support a broad range of quality system and assurance activities, using data and cross‑functional collaboration to assess issues, document outcomes, support investigations, and contribute to continuous improvement across the division. This is a fully qualified, career‑level role for an experienced professional who can work independently, exercise sound judgment, and resolve a wide range of quality‑related issues

Formación

• Experience in Quality Assurance or Quality Systems in regulated environments.
• Experience with CAPA processes and effectiveness checks.
• Ability to analyze data and develop KPIs and quality metrics.
• Familiarity with audit preparation and regulatory inspections.

Responsabilidades

• Support quality values and system requirements across the division.
• Collaborate with team members and cross-functional teams.
• Coordinate quality activities under the QA Manager supervision.
• Lead CAPA processes including corrective and preventive actions.
• Provide guidance on root cause evaluation and CAPA effectiveness.
• Review CAPA system daily and coordinate resource needs.
• Maintain and improve the divisional CAPA toolbox and materials.
• Prepare and manage documentation from CAPA Review Board meetings.
• Serve as contact for CAPA process and support global process improvements.
• Participate in internal and external quality audits and inspections.
• Assist with data analysis and KPI development.
• Review open Quality Plans and provide updates.

Conocimientos

Quality Assurance

Root Cause Analysis

Data Analysis

Communication

Cross‑functional Collaboration

Educación

Technical Bachelor's degree

Herramientas

Agile PLM

QMS software

Descripción del empleo

Hologic, Inc. currently has two openings for a CAPA Facilitator Associate.

You will support a broad range of quality system and assurance activities, using data and cross‑functional collaboration to assess issues, document outcomes, support investigations, and contribute to continuous improvement across the division. This is a fully qualified, career‑level role for an experienced professional who can work independently, exercise sound judgment, and resolve a wide range of quality‑related issues