Associate Spec. QA DMR (Medical Devices)

Location: Wuhan, China; onsite

Company

hirify.global manages quality processes and product documentation for its medical products.

What you will do

• Collect and verify Device Master Record documents in line with regulatory requirements and project schedules.
• Draft inspection criteria for new finished goods and update existing criteria in the ETQ quality management platform.
• Maintain inspection criteria for daily inspection use and upload verified supplier records to the quality system.
• Review supplier change control requests, component sourcing forms, and supplier documentation; assign Quality Warning codes where required.
• Support new product sample build reviews, supplier specification clarification, and periodic supplier re-evaluations.
• Prepare monthly Complaint Trending Reports and complete assigned quality projects and ad-hoc tasks.

Requirements

• Ability to support quality assurance activities for Device Master Records and inspection criteria.
• Ability to collect, verify, review, and maintain controlled quality documentation.
• Understanding of ISO 13485 and CFR 820 requirements.
• Ability to work under supervisor and DQA team guidance on supplier quality and product documentation activities.

Culture & Benefits

• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working an average of at least 30 hours per week.
• Employees working fewer than 30 hours per week receive 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
• Inclusive workplace focused on belonging, diversity, career growth, and providing resources for effective work.