• Directly lead 2 sub-teams, DCU (customer complain) and QMS (incl. QMS, CAPA and Document Center);
• Guarantee quality management system (QMS) be established/maintained/optimized well within SSMR-MR;
• Responsible for external and internal QMS audit;
• Insure SSMR-MR compliance with ISO13485, MDSAP, Country regulation and Siemens Healthineers directives etc.;
• Drive quality continuing improvement for product and internal process (via. CAPA) and post market quality, like complaints, MTBFspc.;
• Reporting decision make for adverse event;
• Cooperate with ERMR and SMT to complete global cross-sites QMS and PMS relevant projects.
• Minimum 5 years working experience in Medical Device Manufacture;
• Expert in Regulation & Quality Management System of Medical device; (IS0 9001/ISO 13485/EU MDD/EU MDR/MDSAP/NMPA GMP etc.)
• Expert in external and internal audit handling;
• Expert in product safety and risk management;
• Good at people management, coaching skill & open-minded;
• Fluent in English, familiar with different national culture and high ability to lead cross-sites discussion.
• Bachelor degree or above on Engineering, or other relevant qualification.
Organization: Siemens Healthineers
Company: Siemens Shenzhen Magnetic Resonance Ltd.
Experience Level: Experienced Professional
Job Type: Full-time