C-RAD is a medical technology company that produces surface guided radiation therapy (SGRT) solutions to increase treatment accuracy and patient safety in the entire radiation therapy workflow.

As a Quality Leader, you will implement and maintains China GMP & ISO 13485 quality management systems, create and maintain all quality processes/documentation, ensure compliance of personnel to the QMS through coaching and training, fulfill requirements on quality issues and workclosely with the management team in fulfilling all of the above.

Responsibilities include:
* Act as quality representative for legal entity to maintain the QMS system

* Oversee and maintain compliance with China GMP, MDR 2017/745/EU, ISO 13485 and USA 21 CFR 820

* Review and consolidate product requirements for medical device systems developed at C-RAD according to applicable regulations

* Contribute actively to defining medical device documentation, from user needs and applicable standards, to design verification testing, and give appropriate guidance to the development teams

* Work in collaboration with the Legal team to prepare manufacturing and quality agreements
with CMO，external providers and suppliers

* Work effectively in close collaboration with external providers or suppliers and perform
quality audits

* Create and maintain all quality documentation related to products, including product test
protocols, change management and notification processes, corrective and preventative actions (CAPA), customer complaints, audits and related items

* Train and coach C-RAD teams to use, follow and work under QA Processes along the projects

* Oversee the risk management process and oversee its related activities

* Act as the main source of quality and regulatory knowledge and strategy within C-RAD

* Report to management on quality issues, trends and effectiveness.

Profile
* MS in Engineering or relevant Life Science discipline with 5+years of experience in a similar
position in the medical device industry (preferably with class III medical devices)

* Detailed understanding of the China, EU and USA medical device regulations, including the China GMP, MDR 2017/745/EU, the FDA 21 CFR Part 820 and ISO 13485 requirements

* Experience with setting-up and maintenance of Quality Management Systems and Processes for Medical Devices

* Demonstrated skills in risk management (ISO 14971) and documentation compliant with
standards and guidelines of the medical device industry (e.g., technical documentation,
design history file, Investigational Device Exemption)

* Experience managing a small team of QA Engineers

* Strong organizational and communication skills, , including ability to communicate with
academic scientists and internal clinical teams

* Successfully stay within defined budgets and schedules

* Work independently and within a team

* Possess a positive, “can-do” attitude

* Strong at taking initiative, fast learner

* Attention to details

* Fluency in written and oral English.