Quality Specialist

Quality Specialist

About the Role

Our client, a global organization with a strong focus on quality, is seeking a dedicated Quality Specialist to join their team in Columbus, Georgia . This is an onsite position crucial for managing quality processes, addressing customer complaints, and driving continuous improvement. You'll work closely with cross-functional teams to ensure adherence to the Global Quality Management System and maintain a state of compliance. This role offers excellent opportunities for professional growth and involvement in key business processes.

Key Responsibilities

• Process Management & Compliance :
• Manage and execute quality processes, ensuring end-to-end adherence to the Global Quality Management System (QMS) .
• Coordinate the workflow of complaints, ensuring they are accurately documented and managed within the EQMS system .
• Monitor and support the implementation of Product Notification Initiatives (PNI) very early in the product lifecycle.
• Ensure all written communications, including customer responses and technical documentation, are drafted in a compliant manner .
• Participate in management reviews and track Key Performance Indicators (KPIs) .
• Corrective and Preventive Action (CAPA) :
• Investigate and analyse issues to determine the root cause of customer complaints and process deviations.
• Develop, write, and implement effective Corrective Actions and Preventive Actions (CAPA) .
• Work collaboratively with various departments to ensure timely and effective completion of CAPA tasks.
• Quality Operations :
• Oversee validation work for manufacturing sites.
• Conduct or support inspections of incoming material.
• Assist in preparing for and conducting Quality Audits and supplier visits .
• Customer & Stakeholder Interaction :
• Provide clear, professional, and timely customer responses .
• Serve as a key interface, working closely with teams to understand the root cause of customer issues.
• Manage regulatory impact and project timelines (reg impact Timeline management).

Qualifications & Experience

Required :

Work Environment & Benefits

Application

If you are a driven quality professional with a passion for compliance and process improvement, and you are ready to take on a challenging role in a global organisation, we encourage you to apply!