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SSMR MR QMS 经理 QMS Manager

Job Description

Responsibilities

• 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.


Requirements

• 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

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