Quality Manager, RMS

Position Summary

The Quality Manager of RMS take the overall quality management responsibility for RMS portfolio, which includes both clinic products and industrial products. He/she must have deep knowledge of medical device related certifications and regulations.

Main Tasks

1. Lead Quality department and make ensure that operating strategies and procedures are aligned with general company goals meanwhile also meet different division or legal entities business needs.

2. Being centrally responsible for Quality Management Systems (QMS) of legal entity (manufacturing, R&D, distribution,

3. Lead quality assurance team, including quality engineer team, incoming/in-process/finished goods inspection team, and supplier quality management team.

4. Develops and implements quality planning, inspections and defect corrective/preventive action processes and other quality system requirements to determine acceptability of product disposition for new and existing products.

5. Serves teams as a subject matter expert in key quality elements, e.g change control, process validation, NCs, CAPA program and organize the release of products

6. Ensure robust verification & validation processes are established for product design transfer and manufacturing transfer.

7. Provide quality approvals of relevant procedures, SOPs, and plans, procedures and reports for verification and validation activities.

8. According to the requirements of quality control procedure, identify quality control points and develop management procedures. Ensure that the personnel of the department have received relevant training with relevant theoretical knowledge and practical operation skills. Analyze, judge and deal with the actual problems in quality management.

9. Monitor incoming parts quality performance to meet purchasing control requirement and relevant specs.

10. Support RA and QMS on product registration, fulfill requirements according to regulatory authorities, especially NMPA

11. Support QMS department to ensures the organization remains compliant with the QMS through internal audits and coordinating external audits with notifying bodies and local authorities.

12. Review verification documents and the updated DHFs for sustaining products.

13. Identify environmental factors and develop and implement environmental improvement projects at work.

14. Continuous improvement of quality system.

15. Other tasks assigned by line manager.

Requirements

Education

Bachelor or above, majored in mechanical or engineering

Experience

1. More than 5 years in,quality management system, quality assurance/control, and related functional area

2. comprehensive knowledge, skills and experiences for implementation of ISO9001, ISO13485, FDA, IVDR and NMPA regulations for R&D and manufacturing companies obtain internal auditors for respective certifications and regulations

Other skills

1. Strong leadership to establish and manage a capable team to ensure outstanding quality performance for RMS products.

2. Rich problem-solving skills to handle quality topics among authorities, customers, supply chain and internal departments

3. Excellent interpersonal communication and teamwork; abilities to work in cross-functional and cross-culture teams.

4. Well oral and written English skills.

5. Statistics and process excellence skills in addition to established quality methods (e.g. Six Sigma, Lean, 8 D-method, CAPA, etc.)

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