Technical Leader Regulatory Verification

Fresenius Medical Care

🇨🇳 China
Hybrid
Senior
3 weeks ago

Risk Management
IEC
Microsoft Word
Excel

3 weeks ago

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Job Responsibilities1) Main tasks:Tasks performed regularly which form the essential characteristics of the position,• Organization and execution of product verification of medical products, accessories and modules.• Ensure that product requirements are testable• Definition and coordination of test strategies• Planning and organization of the system verification incl. Coordination with other departments, projects and external labs• Planning and organization of necessary resources• Creation of test specifications, test cases and test activities• Definition and creation of test set-ups• Familiar with various testing equipment to perform defined testing.• Execution of system verification to ensure that the design input has been achieved• Identification, analysis and documentation of deviations• Creation of associated verification documents acc. to internal and external requirements• Ensure that such documentation is audit-proof• Coordination of necessary verification measures in the design change process• Play the role of an independent reviewer for high level design reviews2) Secondary tasks:Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position. • Consultant in regard of internal and external standards requirements • Risk management• Internal and external requirements (such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-16 etc.)• Coordination of regulatory approval activities• Quality assurance for approval submission documentation• Organize and draft approval submission documentation• Strong technical support to the Team, Method and Lab Running• Be a professional at samples preparing, operating, debugging & simulating according to the project needs3) Miscellaneous tasks:Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.• Other tasks assigned by superior leaderQualifications, experience, know-how and skills critical for success*1) Required training and education:• BS or MS in EE/ME/BM Engineering or related filed2) Required professional experience (in years):Please list the minimum number of years of professional experience required, as well as all relevant experience in specific functions, e.g. project management or line management experience.• Verification Engineer--Minimum 3 years in Medical R&D related area (Prefer HD area)• Sr. Verification Engineer--Minimum 5 years in Medical R&D related area (Prefer HD area)• Technical Leader--Minimum 8 ears in Medical R&D related area (Prefer HD area)3) Important personal qualities:Please list the qualities that are of special significance for the successful performance of tasks if they have not been outlined sufficiently in a attached competence profile.• Ownership & Responsibility• Hard working, focusing on Quality & Details.• Team player, good communicator4) Other specialized knowledge:a) Technical knowledge • Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)b) Languages • Strong English verbal and written communication skills.c) IT skills • Have excellent skills with general computer use and office applications such as Microsoft Word, Excel, and Power point.d) Product knowledge • Familiar with medical device industry and knowledge of HD dialysis machine preferred5) Special personal requirements:Please list requirements such as willingness to travel or work weekends or shifts etc.• Willingness to travel if business required and • Be comfortable working in a global organization• Be comfortable working under pressure

Technical Leader Regulatory Verification · Fresenius Medical Care

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