Your tasks and responsibilities:
•Leading or participation on validation and qualification activities, such as SVMP, validation protocol and report, execution monitoring for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China. Will work closely with the other project core team leads/functions to ensure that processes are appropriately qualified/validated in a timely manner.
•Leading or participate on design historical files transfer activities from sending site to receiving site; coordinating design review/manufacturing transfer review; reviewing and consultant for design change.
•Leading or participate on risk files transfer activities from sending site to receiving site and drafting activities for process, equipment, facility; reviewing and consultant quality case(nonconformity and change) risk analysis.
•Leading establishment on process of post-market quality activities, such as complaint, Field Actions, Adverse Event etc).
•Other related projects or tasks assigned by superior or company.
Your qualifications and experience:
•A minimum of 5 years in medical device , biotechnology or pharmaceutical industry, with a Quality Engineer role. Majority experience in at least 3 of 5 areas and have some experience or knowledge of other two.
•Individualy handling Quality Engineer activities in at least 2 areas and have experience of activities in other area with guideline from others.
•Have product transfer experience or manufacturing establishment experiences are preferred.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Experience Level: Experienced Professional
Job Type: Full-time