QA Leader

Job summary:

Establish and maintain Quality Management System of the company's R&D site to be compliance with applicable health authorities’ regulations, ISO and the global requirements.

Support product design projects, ensure those projects can be completed within time and meet quality, regulatory compliance and business requirements.

Responsibilities:

Lead establishment, implementation and improvement of quality management system.

Promote Quality awareness within Design group, include training, internal audit, periodic review and routine monitoring.

Oversee the routine design related activities in the company's R&D site, ensure the design activities are implemented according to pre-defined requirements, compliance with regulations.

Ensure that design controls are effectively implemented throughout the product development lifecycle. Oversee risk management activities, including identifying potential risks associated with the product and developing risk mitigation strategies.

Work with relevant functions to select and develop suppliers. Manage qualified suppliers’ performance to fulfill compliance and business needs.

Communicate with customers on quality related topics.

External audit management, include customer audit, health authorities audit and 3rd party audit.

Drive continuous improvement of quality within company.

Deal with other assignments from superior.

Qualification:

Bachelor or above, life science or engineering related major are preferred.

Above 6 years’ relative work experience on design quality management in healthcare industry, such as pharmaceutical, medical device company. Experiences on ISO certification or health authority permission application are preferred.

Rich experiences on quality system set up and quality team management.

Good communication and leadership skill.

High level of integrity, capable to report sensitive issues to top management.

Fluent in English.