Quality Compliance Audit Manager (Medical Devices)

Location: Remote, United States; frequent travel to manufacturing and operational sites is required. Relocation is not available.

Salary: $122,735–$153,419 annually

Company

hirify.global Medical develops, manufactures, and markets medical products and healthcare services, including infusion therapy, pain management, nutrition, pharmacy compounding, wound care, ostomy care, and dialysis solutions.

What you will do

• Lead internal and supplier audit programs across manufacturing and operational sites.
• Drive compliance with FDA, ISO, MDSAP, and other international regulatory requirements.
• Conduct regulatory gap assessments and lead implementation projects for new and revised requirements.
• Maintain and continuously improve the Quality Management System with manufacturing and quality teams.
• Support regulatory inspections, third-party audits, certification activities, and audit response management.
• Develop compliance training and provide expert guidance on regulatory trends and quality strategies.

Requirements

• Bachelor’s degree in a scientific, engineering, or related discipline; a master’s degree is preferred.
• 10+ years of experience in Quality, Regulatory Affairs, Compliance, Auditing, or a related regulated industry.
• Strong knowledge of FDA regulations, ISO 13485, MDSAP, and global quality systems.
• Experience leading audits, regulatory inspections, and compliance improvement initiatives.
• Excellent project management, communication, and cross-functional leadership skills.
• Ability to travel frequently for audits and site compliance activities.

Nice to have

• ASQ, ISO Lead Auditor, or equivalent professional quality or auditing certification.
• Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.
• Supplier quality management and audit program development experience.
• Experience with regulatory inspection readiness, response management, and global regulatory implementation.

Culture & Benefits

• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Focus on continuous improvement, safety, knowledge sharing, and healthcare quality.