SHD Quality Director/Sr. Manager-Shanghai (职位编号：53458544)

breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go

beyond your comfort zone in order to grow personally and professionally.

Responsibilities:

1. Ensure the company to be compliance with China GSP requirement

2. Develop, implement, and maintain a comprehensive quality management system

(QMS) that encompasses all aspects of the company's operations.

3. Lead and manage the quality team, providing guidance, training, and

performance evaluation to ensure that all quality-related activities are

carried out effectively and efficiently.

4. Oversee the continuous improvement of the QMS, conducting regular internal

audits and management reviews to identify areas for enhancement and ensure the

system's effectiveness and suitability.

5. Work with cross-functional teams to establish and update quality

procedures, work instructions, and forms to ensure consistency and compliance

throughout the organization.

6. Manage the documentation control process, ensuring that all quality-related

documents are accurate, up-to-date, and readily accessible to relevant

personnel.

7. Drive the implementation of quality metrics and key performance indicators

(KPIs) to monitor and measure the performance of the QMS and the quality of the

products and services. Analyze data and trends to identify opportunities for

improvement and take appropriate corrective and preventive actions.

8. Act as the primary contact with regulatory authorities during inspections,

audits, and other regulatory interactions. Prepare the company for regulatory

inspections, coordinate the inspection process, and ensure timely follow-up on

any inspection findings and corrective actions.

9. Act as a liaison between quality and other functions to resolve

cross-functional issues and promote a seamless flow of information and

cooperation.

10. Support entrusted manufacturer decision-making processes, providing

quality-related insights and recommendations to support the overall strategic

goals of the organization.

11. Participate in industry associations, conferences, and working groups to

stay informed of the latest industry trends, best practices, and regulatory

developments. Share knowledge and experience with peers in the industry to

contribute to the overall improvement of the in vitro diagnostic medical device

industry.

12. Undertake special projects or assignments as directed by the senior

management to support the company's growth and strategic initiatives. These may

include initiatives related to quality system optimization, process

improvement, or new product introduction.

13. Prepare and present regular reports to the management review on the status

of quality management activities.

Requirements:

1. A minimum of 15 years of experience in quality management in MD industry or

IVD industry with at least 5 years in a leadership role.

2. Proven experience in developing, implementing, and maintaining a quality

management system in accordance with regulatory requirements.

3. Familiarity with product development, validation, and verification

processes for in vitro diagnostic devices.

4. Experience in handling regulatory inspections, audit.

5. A bachelor's degree in a relevant field such as biomedical engineering,

chemistry, biology, or a related science discipline is required. A master's

degree or higher is preferred.

Our global team:

We are a team of 66,000 highly dedicated employees across more than 70

countries passionately pushing the boundaries of what’s possible in healthcare

to help improve people’s lives around the world. We aspire to create better

outcomes and experiences for patients no matter where they live or what health

issues they are facing. Our portfolio, spanning from in-vitro and in-vivo

diagnostics to image-guided therapy and innovative cancer care, is crucial for

clinical decision-making and treatment pathways.

Our culture:

We are part of an incredible community of scientists, clinicians, developers,

researchers, professionals, and skilled specialists pushing the boundaries of

what’s possible, to improve people’s lives around the world. We embrace a

culture of inclusivity in which the power and potential of every individual can

be unleashed. We spark ideas that lead to positive impact and continued success.

As an equal opportunity employer, we welcome applications from individuals

with disabilities.

We care about your data privacy and take compliance with GDPR as well as other

data protection legislation seriously. For this reason, we ask you not to send

us your CV or resume by email. We ask instead that you create a profile in our

talent community where you can upload your CV. Setting up a profile lets us

know you are interested in career opportunities with us and makes it easy for

us to send you an alert when relevant positions become open.

To all recruitment agencies: Siemens Healthineers does not accept agency

resumes. Please do not forward resumes to our jobs alias, employees, or any

other company location. Siemens Healthineers is not responsible for any fees

related to unsolicited resumes.