Quality Assurance Specialist – Device Master Record (DMR)

About the role

We are looking for a Quality Assurance Specialist to manage Device Master Record (DMR) documentation for Medline’s medical products. The role ensures that inspection criteria are established, maintained and communicated across internal teams and suppliers, supporting regulatory compliance and product quality.

Key responsibilities

• Collect and review DMR documents for Medline products in line with regulatory requirements and project plans.
• Establish, update and maintain inspection criteria for new and existing products on the ETQ quality management platform.
• Provide training to internal and external stakeholders on DMR procedures and inspection criteria.
• Conduct change control reviews of supplier documents and assist suppliers with required changes.
• Review sample constructions for new products and guide suppliers on specifications.
• Prepare monthly complaint trending reports and implement improvement actions as needed.
• Perform supplier re‑evaluation and assign Quality Warning codes based on review results.
• Implement process improvements and share best practices with the team.
• Participate in additional projects assigned by managers or DQAs.

Required profile

• Bachelor’s degree (minimum).
• 3–5 years of professional experience, including at least 2 years in quality control or supplier quality management.
• Understanding of supplier manufacturing and inspection processes.
• Familiarity with regulatory standards, risk assessment and historical adverse events.
• Knowledge of ISO 13485 or ISO 9001 is a plus.
• Excellent verbal and written English (CET‑6 certification preferred).

Required skills

• ETQ quality management platform.
• ISO 13485 quality system.
• ISO 9001 quality system.

What we offer

• Health, life and disability insurance.
• 401(k) retirement contributions.
• Paid time off and employee assistance programs.
• Inclusive culture that supports career growth.