About this role
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
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 Bachelor degree with 10 years working experience At least 8 years of experience in QMS management in Medical business Proven experience in establishing and management of Medical quality systems Proven experience in leading ISO 13485 audits.
- Good communication skills and be fluent in oral English