Description

You will manage quality systems and ensure products and processes conform to established standards and regulatory requirements.

Responsibilities

• Lead the Global CAPA team by overseeing deliverables, training, and system oversight.
• Investigate and resolve system nonconformances identified during internal and external audits.
• Own the reporting and publishing of weekly, monthly, and quarterly quality metrics.
• Develop and maintain QA procedures, forms, systems, and databases.
• Act as the lead representative for presenting QA systems to internal and external auditors.
• Guide team members through product review, data analysis, and risk assessments.

Required Skills

• 5+ years of experience in Quality Assurance or Quality Engineering.
• Proficiency in managing CAPA (Corrective and Preventive Action) systems.
• Hands-on experience with Risk Assessment.
• Direct experience managing QA Systems.
• Knowledge of FDA regulations and Quality Management Systems (QMS).
• Ability to track and identify manufacturing-related complaints.
• Experience with Environmental Management Systems (EMS) and regulatory compliance.
• Proven ability to lead meetings and communicate QA updates to stakeholders.

Key Skills

Education

Any Gradute