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.

1.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.

2.Implement and comply with the Natus Medical Incorporated Quality Management System to the highest standards.

3.Contribute to continuous improvement of systems and practices, active membership on cross functional continuous improvement teams.

4.Review company systems and procedures to ensure effectiveness and recommend improvement opportunities.

5.Support activities during regulatory inspections and audits.

6.Assist or lead production improvement activities.

7.Support key QA activities, as assigned, which may include, e.g., nonconformance handling, training activities, production improvement activities, process validations, supplier audits.

8.Assist in preparing quality related metrics in support of product and process improvement activities and quality reporting in management review.

9.Support Quality efforts with production line transfer and outsourcing efforts.

10.Perform internal quality system audits per procedure to maintain compliance with international and domestic standards and regulations.

11.Adverse events handling and Period Risk Assessment reports initiation.

12.Surveillance to post-market according to China local regulatory.

13.Any additional tasks deemed necessary by management.

Travel Required:moderate.

EDUCATION AND/OR EXPERIENCE:

•Bachelor's degree (B.A.) from four-year college or university in a clinical/medical/biological engineering related discipline;

•5 years related experience in Medical Device Company and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS:

•Ability to read, write the reports in English.

•Good understanding and translation ability between Chinese and English.

•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.

OTHER SKILLS AND ABILITIES:

•ISO 13485 Internal Auditor Certification (required)

•Knowledge of Medical Devices regulatory requirements for China

•Experience in China GMP

•Experience in China GSP with class III product

•PC experience required (working knowledge of Microsoft Office).

•Ability to multi-task and work under pressure.

•Good communication skills for cross-department.

•Minimum 5 years’ experience in a similar role in active medical device field.