Siemens Healthineers SHDM QMS Specialist (Shanghai) 西门实验系统（上海）有限公司 质量体系专员（工作地点：上海）

Job description

Job Description

Mission/

Position Headline:

As member of the China Project team, the primary responsibility for this role will be assisting QA manager and Core Team Quality Lead with the development and implementation of the China facility Quality System.This position also will assist in the Quality Assurance Management System building-up and operation to ensure the system is comliance with all domestic and global regulatory and corporate requirements.

Areas of Responsibilties:

· Integration of Siemens Healthineers global and Walpole's quality system requirements into China facility quality system that is compliant with CFDA requirements, with an emphasis on the following QMS processes:

o CAPA

o Internal audit

o Change Management

o Management Review

o Quality Continous Improvment

· Provide support to the China Quality team to ensure that the Quality Management System is fully implemented in the organization accoring to Project Plan.
· Interact with relevant regulatory agencies and assist in the regulatory agency inspections, participate in acquisition of Manufacturing license application, maintenance and renew.
· Assist in other quality activieits asigned by QA Manager, sucha s support GMP related training organized by Training Department.
· Other related projects or tasks assigned by superior or company.

Dimension of Function/Volume:

N/A

Contacts
(internal/external):

Related functions in SHDM; related departments in US site

Education and Experience

Experience

· A minimum of 3 years in the pharma and medical device industry.
· Prior experience working in an CFDA regulated environment.
· Prior experience with facility start-ups, or other major projects is preferred, e.g. quality system remediation efforts or deployment projects.

Education

A minimum of a 4 year degree is required.

Competence and Knowledge (if applicable)

Interpersonal & Personal – Function & Methods – Technology & Market

Competence Category

Competence

Title

Competence

Level

Description

Interpersonal & Personal

Communication

Advanced

Excellent verbal and written communication skills in both English and Chinese.

Interpersonal & Personal

Teamwork and collabration

Advanced

Must be able to work collaboratively with other project team members.

Function & Methods

Quality methods

Advanced

Excellent understanding and practical application of medical device quality system regulations including CFR 21 Part 820 (QSR), ISO 13485, CFDA Regulation , and other domestic and international regulations that may apply.

Function & Methods

GMP knowledge

Basic

Knowledge of CFDA IVD GMP requirements.