Natus

SUMMARY: 

The Quality Manager has responsibility for the assurance of the Quality System at the Shanghai site; adherence to local regulatory requirements, China GSP 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 GSP Quality System procedures related to this job, which can affect the quality of imported products or services provided to our customers. 

2. Act as Quality Responsible Person for Shanghai site.

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

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

5. Be familiar with Class III distribution management.

6. Lead GSP regulatory inspections and audits.

7. Assist or lead distribution improvement activities.

8. Submit annual reports online which SHFDA required.

9. Initiate GSP Quarterly Report according to regulatory.

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

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

12. Surveillance to post-market according to China local regulatory, as assigned, which may include, e.g., nonconformance handling, CAPA, training activities etc..

13. Any additional tasks deemed necessary by management.

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.
• 10+ 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.

EEO Statement:

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.