Quality Lead (MedTech)

Location: Suzhou, Jiangsu, China; onsite

Company

hirify.global develops vital organ therapy products, digital solutions, and advanced services focused on improving kidney care and patient outcomes.

What you will do

• Maintain and continuously improve the Quality Management System in line with GMP, GSP, corporate QMS, and applicable regulatory requirements.
• Supervise critical production processes, review batch production records, ensure data integrity, and oversee product release.
• Manage NCR and CAPA processes, lead deviation investigations and root cause analyses, and ensure timely closure.
• Lead change control, including impact assessment and verification or validation before implementation.
• Optimize, improve, and simplify the company’s quality system architecture while maintaining control of CQAs and CPPs.
• Manage team performance and talent development, strengthening capabilities and building a compliant, collaborative quality culture.

Requirements

• Experience maintaining and improving quality management systems in a regulated manufacturing or healthcare environment.
• Knowledge of GMP, GSP, corporate quality systems, and applicable regulatory requirements.
• Experience with batch record review, product release, data integrity, NCR/CAPA, deviation investigations, and root cause analysis.
• Ability to lead change control and assess verification and validation requirements.
• Experience managing team performance and developing quality talent.

Culture & Benefits

• Mission-driven work focused on extending lives and improving patient and care-team outcomes.
• Work within a quality culture emphasizing compliance, collaboration, continuous improvement, and operational efficiency.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.