Assoc Spec QA DMR (Medical Devices)

Location: Shanghai, China

Company

hirify.global develops and supplies medical products and maintains quality systems for regulated healthcare manufacturing.

What you will do

• Collect and verify Device Master Record documents for hirify.global products against 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 support supplier change control documentation.
• Participate in new product sample build reviews and help suppliers understand product specifications.
• Prepare monthly Complaint Trending Reports and revise them based on DQA feedback.
• Support supplier re-evaluations, review Component Sourcing Forms, assign Quality Warning codes, and verify COC/COA records.

Requirements

• Bachelor’s degree or higher.
• 3–5 years of work experience, including at least 2 years in quality control or supplier quality management.
• Understanding of supplier manufacturing and inspection processes.
• Knowledge of regulations, standards, risk assessment, customer needs, historical adverse events, and inspection criteria.
• Experience with quality systems such as ISO 13485 or ISO 9001 is an advantage.
• Excellent verbal and written English; CET-6 certification required.

Culture & Benefits

• Full-time employment with health insurance and life and disability coverage.
• 401(k) contributions and paid time off for employees working 30 or more hours per week on average.
• Access to an Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
• Inclusive workplace focused on belonging, diversity, and career growth.