Sr Engineer QA

Location: Shanghai, China; onsite

Company

hirify.global develops and manufactures medical products while maintaining quality, compliance, and continuous improvement across its operations.

What you will do

• Analyze product designs and identify opportunities to improve product performance.
• Coordinate with US quality and R&D teams on process quality and regulatory compliance improvement projects.
• Work with suppliers and vendors to establish, optimize, and monitor production and quality processes.
• Analyze process quality data, conduct supplier audits and assessments, and drive corrective action plans.
• Identify root causes of quality issues, lead recall investigations, and manage CAPA and SCAR activities through effective closure.
• Review design control and design transfer documentation, conduct onsite validations, and share quality and manufacturing knowledge with the team.

Requirements

• Experience in quality assurance and manufacturing process quality.
• Experience with supplier audits, supplier assessments, and production process controls.
• Ability to perform quality data analysis and root-cause investigations.
• Experience managing CAPA and SCAR activities and verifying corrective action effectiveness.
• Knowledge of design controls, design transfer, validation documentation, and applicable regulations.
• Ability to collaborate with quality, R&D, suppliers, and vendors.

Culture & Benefits

• Full-time employment with health insurance, life and disability coverage, paid time off, and 401(k) contributions as applicable.
• Access to employee assistance, employee resource groups, and employee service programs depending on working hours.
• Inclusive workplace focused on belonging, diversity, career growth, and access to professional resources.