Quality Manager - Medical Devices

About the Role

The Quality Manager leads and improves the ISO 13485 Quality Management System within a regulated manufacturing environment, supporting medical device packaging operations. They serve as the site quality leader, collaborating with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and uphold customer confidence.

Responsibilities

• Manage and maintain the QMS, oversee document control, conduct management reviews, and ensure audit readiness.
• Manage CAPA, nonconformance, and risk management activities in line with ISO standards.
• Support validation, process improvements, and supplier quality programs.
• Handle customer complaints, analyze trends, and serve as escalation point for quality issues.
• Lead and develop quality personnel, set departmental goals, and provide guidance across departments.

Requirements

• Bachelor's degree in Engineering, Quality, or related field.
• 5+ years of experience in regulated manufacturing.
• 3+ years of experience with ISO 13485, audits, CAPA, risk management, and supplier quality.
• Strong leadership, communication, and problem-solving skills.
• Experience in FDA-regulated environments is preferred.

Skills

• Organized and detail-oriented.
• Effective communicator and risk-based decision-maker.
• Capable of balancing compliance with operational needs.
• Technical expertise in ISO 13485, CAPA, risk management, validation, and document control.