Position Statement
1. Establish and monitor product quality objectives throughout the product lifecycle.
2. Oversee quality assurance in design, procurement, production, and post-market stages.
3. Lead product verification during design/change phases (e.g., validation plans, test methods, report reviews).
4. Supervise production quality compliance and supplier quality management.
5. Manage post-market surveillance, customer complaints, recalls, and CAPA implementation.
6. Drive process optimization and act as a quality engineering expert in risk management.
7. Maintain communication with regulatory bodies and testing agencies.
Qualification
1. Bachelor’s degree or higher in Mechanical, Materials, Chemistry, Biology, or related fields.
2. 5+ years in medical device QA, with 3+ years in design verification, production, or post-market QA. Experience in sterile devices and team management preferred.
3. Knowledge of ISO13485, China GMP, and medical device regulations. ISO13485 auditor certification required.
4. Proficiency in MS Office, quality tools, and English.
5. CQE, Six Sigma Black Belt preferred.
6. Strong leadership, systematic thinking, and problem-solving skills.