南京招聘

I. Principal Accountabilities

1. Establish incoming, in-process, and final inspection product inspection standards.

2. Oversee measuring device calibration program.

3. Manage Continuous Improvement Actions (CAPA System).

4. Assure quality lab equipment is kept in working condition.

5. Manage complaint investigation process & ensure corrective actions initiated.

6. Ensure master samples, procedures, etc. used in inspection process are up-to-date.

7. Analyze quality control data, initiate process improvements, & report on monthly status.

8. Participate in supplier quality audits.

9. Assure that product listings are submitted in accordance with all applicable regulations.

10. Manage adverse event (MDR) reporting.

11. Review and approve labeling to assure compliance with applicable regulations.

12. Ensure that processes needed for ISO13485 QMS are established, implemented and maintained. Manage internal audit and other ISO13485 activities.

13. Liaise with external parties on matters relating to regulatory and the quality management system.

14. Lead and assist in developing Quality System Training.

15. Supervise Quality Control staff.

II. Functional Knowledge, Skills & Abilities

This position requires an individual with:

1. University graduate with Bachelor degree or above.

2. Excellent communication skills, active team player.

3. Above 5 years hands-on experience in Quality Assurance.

4. ISO9000 or ISO13485 internal audit experience; Knowledge of ISO13485.

5. Work well with minimal supervision, balancing a variant of tasks and priorities.

6. Computer literate and comfortable using MS Word, Excel, and Powerpoint Softwares.

7. Fluent in written and spoken English.

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