17-Nov-2018, Ad#: 18165, Views: 3747 Category: Healthcare & Medical Sciences
Quality Engineer / Regulatory Affairs(Fulltime)
VitalCare (Nanjing) Co., Limited
Job location Jiangsu
Company introduction We are a British-owned medical device company providing OEM products for healthcare brands worldwide. Fast growing, nice 35,000sqft facility in Gaochun, a district about 1 hour to the south of Nanjing. We have a Class 8 cleanroom and a workforce of around 65 people. The technical specialisation in our factory is radio frequency welding of PVC, extrusion of tubing and sub assembly- sterile packing of single-use urology devices.
Job description We are looking for a technically-minded Quality Engineer, working to ensure that manufacturing processes and ultimately, final products, meet both internal and external quality standards. Duties may include:
Maintain and create quality documentation and development of SOPs for the facility and products in line with industry standards
Proactive review and improvement of systems and processes to ensure the maintenance of standards.
Maintaining accurate quality documentation.
Working closely with manufacturing staff and Quality Control department to ensure quality protocols are followed and documentation is correctly maintained
Ensuring safety requirements are met at every point in the manufacturing facility
Analysing problems reported and developing improvements to overcome them
Statistical analysis of manufacturing data and creation of reports for senior staff members based on quality documentation
Working closely with external partners e.g. suppliers, customers, etc
Continuous improvement in the manufacturing process
Annual salary RMB 96000 - 180000
Candidates Both Internationals and local Chinese
Qualifications The successful candidate will already be competent in a ISO Quality Management System such as ISO 9001, although ISO 13485:2016 is a bonus.
Six Sigma and / or knowledge of other techniques to ensure reliability of processes and final product is required.
Engineering / science based qualification to degree level is preferred
Contact VitalCare (Nanjing) Co., Limited Lewis Calcutt, MD VitalCare UK 维克佳（南京）医疗器械有限公 司