CAPA Facilitator Associate - Quality Improvement Pro

Hologic, Inc.; Newark (DE); Sur place; USD 78 000 - 122 000; Plein temps

Résumé du poste

Hologic, Inc. is hiring a CAPA Facilitator Associate to support quality system activities across the division. You will analyze data, drive CAPA processes, and collaborate with cross-functional teams to resolve issues and improve processes.

The role requires independence, good judgment, and experience in medical device or related regulated environments. A technical Bachelor's degree is preferred and an annual base salary range is provided with bonus eligibility.

Qualifications

• Experience in medical device, IVD, or pharmaceutical industry.
• Experience with CAPA processes and quality investigations.
• Understanding of audit preparation and regulatory inspections.
• Ability to analyze data and develop quality metrics and KPIs.

Responsabilités

• Support quality system requirements and best practices across the division.
• Coordinate quality activities and support QA department as directed by QA Manager.
• Facilitate CAPA processes, nonconformance activities, and MR administration.
• Prepare and manage documentation from CAPA Review Board meetings.
• Assist with data analysis and KPI development.
• Support FDA inspections and regulatory audits.

Connaissances

Quality Assurance

QMS

CAPA processes

Root cause analysis

Audits

Data analysis

KPIs

Documentation

Cross-functional collaboration

Formation

Technical Bachelor’s degree or higher

Outils

Agile PLM

Description du poste

Hologic, Inc. is hiring a CAPA Facilitator Associate to support quality system activities across the division. You will analyze data, drive CAPA processes, and collaborate with cross-functional teams to resolve issues and improve processes.

The role requires independence, good judgment, and experience in medical device or related regulated environments. A technical Bachelor's degree is preferred and an annual base salary range is provided with bonus eligibility.