Job Overview

Take responsibility for establishment, implementation and continuous improvement of Quality Management System in Suzhou site, ensure healthy functioning of QMS and overall compliance.

Job Requirements

• Policy and Procedures

Generate local quality policy and procedures according to requirements of global QMS and ISO 13485; Ensure quality policy and procedures are communicated throughout the whole company and strict surveillance the implementation of established processes in functions.

• QMS Maintenance

Maintain QMS adequacy and effectiveness through regular review, audit and trainings, to identify improvement opportunities for continuous optimizing and better support each function . Ensure the fully compliance of QMS and be audit ready.

• Internal Quality Audit

Create internal audit checklist and provide related training for internal auditor. Schedule internal plan and lead annual internal audit. Integrate internal audit findings and identify risk points to optimize procedures and processes.

• External Audit

Lead external audit, prepare and review audit files according to customer or quality agencies audit needs; Perform pre-audit activities to ensure all company is in ready state. Coordinate the entire audit process and complete and submit action plans to customer based on audit report.

• CAPA Management

Create CAPAs based on risk assessment level come from NC, Complaint, audit and so on. Ensure all CAPAs are well implemented and documented according to requirements of ISO13485.

• Management Review

Implement biannual management review. Collect relevant KPI data and prepare management review report. through identify and manage risks to determining if the interaction of Quality System processes is effective and resource are sufficient.

• Global  QMS project

As assigned site representatives, complete gap analysis with respect to requirements of global project, review and update procedures and associated forms. Make training plan and provide training to down level – engineers & operator ensure that everybody knows about the requirements of project. Communicate and coordinate with relative department on implementation of the project smooth development based on global quality plan.

• Document Control

Be responsible for the quality system document review,release and distribution. Implement and develop documentation procedure according to Corporate documentation policy; Maintain documentation system according to TE global document control requirements. 

What your background should look like

1. Bachelor degree with 10 years working experience
2. At least 8 years of experience in QMS management in Medical business
3. Proven experience in establishing and management of Medical quality systems
4. Proven experience in leading ISO 13485 audits.
5. Good communication skills and be fluent in oral English