We are seeking a motivated and detail-oriented intern to support Evinova China’s quality initiatives, with a particular focus on computerized system lifecycle management, Computerized System Validation (CSV), and project quality governance.
This role offers a unique opportunity to gain practical experience in quality management systems, computerized system compliance, and project management within the regulated healthcare technology industry.
Responsibilities
• Support the establishment and continuous improvement of quality management frameworks.
• Support computerized system lifecycle activities and validation-related initiatives throughout planning, implementation, operation, change management, and retirement phases.
• Coordinate with cross-functional teams, to support quality and compliance activities.
• Support project management activities, including action tracking, meeting coordination, timeline monitoring, status reporting, and documentation management.
• Assist in ensuring project activities are conducted in accordance with applicable regulations, industry standards, and internal quality requirements.
Qualifications
• Bachelor’s or Master’s student currently pursuing a degree in Computer Science, Information Systems, Software Engineering, Biomedical Engineering, Quality Management, or a related discipline.
• Strong interest in Quality Management Systems (QMS), Computerized System Validation (CSV), compliance, and project management.
• Basic understanding of computerized system lifecycle concepts and software development processes.
• Familiarity with software applications, cloud technologies, or digital health solutions is preferred.
• Understanding of quality management principles, validation concepts, system implementation, or regulated environments would be an advantage.
• Familiarity with GAMP® 5, Computerized System Validation (CSV), ISO 9001, GxP, or other regulated industry practices would be a plus.
• Strong attention to detail and a commitment to producing high-quality work.
• Demonstrated sense of responsibility, ownership, and accountability.
• Strong problem-solving skills with a results-oriented, self-driven, “can-do” attitude.
• Fluent in both Chinese and English, with strong written and verbal communication skills.
• Able to commit to 3–6-month internship period with at least 3 days on-site in Shanghai per week.