Principal Engineer Quality (Medical Devices)

Location: Shanghai, China; approximately 30% travel to hirify.global facilities and vendor sites, including potential international travel

Company

hirify.global operates in the medical device industry and provides a corporate employment environment with employee benefits.

What you will do

• Serve as the site subject matter expert for validation of manufacturing equipment, sterile packaging, mixing and water systems, filling systems, cleaning processes, and injection molding.
• Define critical process parameters and critical quality attributes for complex manufacturing processes using risk-based approaches.
• Draft, review, approve, and finalize IQ/OQ/PQ protocols and validation reports.
• Lead on-site validation execution and verify test data integrity, accuracy, and traceability.
• Optimize validation SOPs, validation master plans, and validation databases.
• Manage deviations, non-conformances, change controls, corrective actions, audits, and regulatory inspection support.

Requirements

• Bachelor’s degree or higher in biomedical, chemical, mechanical, pharmaceutical engineering, quality management, or a related field.
• 7+ years of experience in the medical device industry with solid IQ/OQ/PQ validation experience.
• Knowledge of ISO 13485, medical device GMP, FDA 21 CFR 820, and EU MDR requirements.
• Knowledge of statistical methods and sampling applications.
• Ability to independently write, review, and approve validation protocols and reports.
• Strong English reading and writing ability is required for understanding and preparing validation documents.

Culture & Benefits

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