Global CAPA Lead - Quality & Continuous Improvement

Socket.dev

Trumbull (CT)

On-site

USD 120,000 - 170,000

Full time

10 days ago

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Job summary

CooperSurgical is seeking a Sr. Global CAPA Engineer to support the execution and effectiveness of the Global CAPA Program across the organization.

The role partners with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, and other functions to ensure timely investigations, robust root-cause analyses, effective corrective actions, and verification. You will lead complex CAPAs, perform quality reviews, monitor trends, and drive continuous improvement while maintaining compliance with

Qualifications

  • Experience leading CAPA investigations and root-cause analysis.
  • Knowledge of regulatory requirements and quality systems.
  • Ability to influence cross-functional teams and drive improvement.

Responsibilities

  • Support execution and effectiveness of the Global CAPA Program.
  • Provide expert guidance on investigation techniques and documentation.
  • Facilitate high-risk CAPAs and improve quality system performance.

Skills

CAPA
Root cause analysis
Quality systems
Regulatory compliance
Cross-functional collaboration

Education

Bachelor's in Engineering or related field

Tools

QMS software
FMEA

Job description

CooperSurgical is seeking a Sr. Global CAPA Engineer to support the execution and effectiveness of the Global CAPA Program across the organization.

The role partners with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, and other functions to ensure timely investigations, robust root-cause analyses, effective corrective actions, and verification. You will lead complex CAPAs, perform quality reviews, monitor trends, and drive continuous improvement while maintaining compliance with

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