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SSMR MR 质量工程师 Quality Engineer (DQE)

Job Description

Responsibilities

- Quality management for Process and Product Support
--consults the R&D management regarding current and future quality/regulatory requirements and risks.
--drives together with the R&D continuous enhance product quality.
--provide quality audit in an independent and objective manner to assure efficiency and effectiveness and compliance with laws and regulations.                                                                               
- Q-coaches for new products and projects 
- Consults the R&D management regarding current and future quality/regulatory requirements and risks                                                 
- Drives together with the R&D management continuous improvement in order to reach world-class quality 
- Provide quality audit in an independent and objective manner to assure efficiency and effectiveness and compliance with laws and regulations
- Has the authority and is obliged to stop any processes and projects in cases where the corresponding quality and regulatory requirements are not fulfilled.

Requirements
- Be familiar with  ISO9001, ISO13485, MDR, MDD, MDSAP, and countries regulation requirements like FDA, NMPA
- Be good at English speaking, frequently communication                                                                                                
- Open mind, transparent, customer oriented thinking.       
- Preferred 2 years or above experiences for medical device development, clinical application, or medical device manufacturing    


Organization: Siemens Healthineers

Company: Siemens Shenzhen Magnetic Resonance Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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