Global Quality Systems Manager (Medical Device)

TL;DR

Global Quality Systems Manager (Medical Device): Maintaining, monitoring, and improving key quality system processes to ensure compliance with applicable regulatory requirements and standards, including ISO 13485. Focus on effective documentation, reporting, and continuous improvement throughout the Quality Management System.

Location: Remote (US)

Salary: $120,000-$150,000 annually

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Provide oversight and governance of QMS processes to ensure sustained compliance and operational continuity.
• Review and approve quality system records to ensure accuracy and alignment with regulatory requirements.
• Lead the development, analysis, and presentation of quality performance metric analysis.
• Evaluate quality data to identify emerging trends, risks, and opportunities for process optimization.
• Manage and support the annual internal audit program.
• Partner with Global cross‑functional leaders to drive compliance and improvement projects.

Requirements

• Bachelor’s Degree in medical device/life science/chemistry or other relevant science field.
• Minimum of 7 years of experience working in regulated quality systems within the medical device industry.
• Minimum of 5 years Quality experience oversight of 3rd party contract manufacturers and / or logistics
• Strong working knowledge of ISO 13485 requirements and quality system principles.
• ISO 13485 auditor certification preferred.
• Ability to manage multiple projects simultaneously while ensuring regulatory compliance

Culture & Benefits

• Diverse teams of passionate people.
• Career that allows you to develop both personally and professionally.
• Make life-saving technology accessible for more people.