工作职责
1. Plan, implement and coordinate activities related to quality system, quality assurance, quality verification, customer problem handling and daily management of the department.
2. Collection and update of domestic/foreign medical device regulatory certifications and related regulations and standards.
3. ISO13485 and GMP quality system audit related matters.
4. Matters related to domestic/foreign medical device clinical trials.
理想人选
1. Have English language skills and need to serve foreign customers
2. More than 10 years of experience in domestic and foreign medical factories or enterprises and as a quality control department supervisor
3. Be familiar with various quality system audits and quality project improvement countermeasure effect tracking, etc.
4. Familiar with domestic/foreign medical device regulatory certification and related regulations and standards
5. Familiar with process sheets, quality reports, etc.
6. Cooperate with business trips