Quality Engineer

Quality & Regulatory      ·          China, Shanghai        ·          Full time

Position Description

Position: Quality Engineer
Requisition ID: 11587
Global Function: Quality & Regulatory
Location: China, Shanghai
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Summary:  

The Quality Engineer has responsibility for the assurance of the Quality System at the Shanghai facility; adherence to local regulatory requirements, cGMP and for compliance of the Quality System.

Essential Duties And Responsibilities include the following. 

 Other duties may be assigned.

Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.

• Maintain the Quality System activities in compliance with ISO13485 and local regulatory requirements.
• Provide QA support for Shanghai manufacturing line, including NCR dispositioning and DHR releases.
• Perform Internal Audits
• Provide support for External Audits
• Perform Supplier Audits
• Support to Customer Complaint process
• Initiate Periodic Risk Assessment Report required by China regulatory authorities.
• Coordinate Adverse Events reporting and Field Corrective Action process.

Travel Required:  moderate.

Qualification Requirements:   

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience         

• Bachelor’s degree (B.A.) from four-year college or university in a clinical/medical/biological engineering related discipline;
• and two to four years related experience in Medical Device Company and/or training; or equivalent combination of education and experience.

Language Skills

• Ability to read, analyze and interpret general business periodicals, professional journals and technical procedures.
• Ability to write reports, business correspondence and procedure manuals.  
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.

Mathematical Skills

• Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.  
• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

Certificates, Licenses, Registrations

• ISO 13485 Internal Auditor Certification (preferred)

Other Skills and Abilities

• Ability to read, write the reports in English.
• Good understanding and translation ability between Chinese and English.
• Knowledge of Medical Devices regulatory requirements for China
• Experience in Internal and External Audits
• Experience in Supplier Audits
• PC experience required (working knowledge of Microsoft Office).
• Ability to multi-task and work under pressure.
• Good communication skills for cross-department .

Physical Demands:   

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear.  The employee is regularly required to work at a keyboard and computer.  Specific vision abilities required by this job include close vision and the ability to adjust focus.

Work Environment:   

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  The noise level in the work environment is usually moderate.

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