北京招聘

Verification Engineer（欧洲独资医疗设备行业公司，要求英语流利，福利待遇优厚）

工作地点：浦东

Main objective/s
Organization and execution of product verification of medical products, accessories and moduls.
Preparation of files for regulatory approvals
Execution of product risk management
Guidance concerning internal and external standards requirements

Responsibilities and Accountabilities
？ Organization and execution of product verification of medical products, accessories and moduls.
Ensure that requirements are testable
Creation of test specifications, test cases and test activities
Definition, creation and validation of test set-ups
Definition and creation of test equipment
Calculation of measurent uncerrtainties/inaccuricies
Release of test specifications as their author
Execution of system verification: Verify that the product fulfills all technical system requirements, external standards and safety requirements.
Identification, analysis and documentation of deviations found during testing.
support engineers during problem solving process
Creation of associated verification documents acc. to internal and external requirements
Ensure that such documentation is audit-proof

Target profile of skills and qualifications
Higher education certificate (Bachelor/Master) in engineering and / or equivalent significant experience in the industry
Teammembership experience
At least 3 years of specific working experience
Medical field
Experience with Medical devices and their special requirements in respect of quality and reliability
Departmental list of core procedures
Integrated Management System (DMS CS1000)
Complaint Handling DMS PQ2010
DMS IN 4000 (Develop Product); DMS LM 23xx (Manage Product Changes)
Electrical Medical Safety Standards (e.g. UL/IEC 60601)
Quality methodology experience like Risk Analysis and FMEA
Requirements Management Software
Configuration Management Tool
MS Project
Business Excellence System (BEST)
Basic Knowledge of Project Management
Risk Management
Regulatory Approval (CE/MDD, 510(k), CSA, SFDA etc.

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