苏州招聘

SCOPE OF THE ROLE AND BASIC PURPOSE
？ Participate in the development of a fully integrated Quality System of Suzhou site. Develop, implement and maintain the NCR/CAPA and Audits Systems. Ensure the company meets all applicable standards required.
？ Maintain and report appropriate Quality business dashboards to monitor the performance of the site Quality Management System.
？ Perform the routine compliance data trending analysis, identify the areas to be improved, provide the improvement suggestions to management team
？ Responsible for creating and maintaining quality documentation for equipment, processes and products to assure the expected quality in accordance with all applicable requirements.
？ Participates in the development and execution of packaging validation in accordance with established DePuy standards for validation and verification activities.
？ Responsible for management of labeling/packaging inspection, qualify inspectors to perform inspection and other activities related to packaging.
？ Qualify inspectors & Operators to perform inspection and other activities related to manufacturing process.
？ Responsible for G R&R execution and protocol and report preparation.

ACCOUNTABILITIES/KEY MEASURES
1. Perform the principal duties of the Senior Quality System Analyst position:
- In connection with other departments in China and Overseas, to guarantee in-time and compliant manufacturing start-up in China in order to support all business objectives.
- Perform routine compliance data trending analysis. Identify opportunities to continually improve Quality, present recommendation and coordinate implementation as applicable.
- NCR/CAPA/Audit observation follow up, make sure all of them investigated and documented properly from compliance standpoint
- Perform or lead internal audit. Make sure all internal audits are performed as scheduled, audit reports are created properly.
- Maintain new IA/NCR/CAPA system for the site and responsible for all tasks associated in accordance with all applicable Quality requirements.
- Lead CAPA review meeting, PA review meeting, and identify related actions with the review team and follow up with individuals to close all actions.
- Ensure compliance and coordinate all preparations for all third party audits (e.g. CFDA, FDA, Notified Body, J&J Q&Cww, etc…)
- Maintain and report appropriate Quality business measurements consistent with the DePuy Worldwide Quality dashboards to continually monitor the performance of the DePuy China manufacturing site Quality Management System.
- Responsible for management of Packaging inspection
- Responsible for management of NC/CAPA/Audit observation for Packaging/labeling related
- Responsible for preparation and maintenance of Packaging/labeling specification/requirements and inspection methods.
- Responsible for validation of packaging process
- Responsible for quality trends analysis for purchased goods.

2. In accordance with DePuy Worldwide Quality strategy, participate to the development of the quality system and its day to day implementation:
- Participate in training or workshop employees and deploy on site the Quality philosophy based on FDA QSRs, ISO 13485 and CFDA requirements.
- Ensures compliance to all GMPs and MDD requirements.
- Conduct internal and supplier quality audits at a Lead Auditor level as required.

3. Perform all job duties in full accordance with:
- The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information.
- All J&J policies and local regulations.
- The policies of the Health Care and Environmental programs.
- The code of conduct policies.

4. Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…).

Required Competencies and Skills
？ Strong technical skills
？ Strong work ethic
？ Influencing Skills
？ Negotiating Skills
？ Effective Communicator
？ Planning & Organizing Skills
？ Judgment
？ Fair & Reasonable Approach
？ Confidentiality
？ Customer and Quality focus
？ Strong ability to work in a cross functional structure
？ Degree in Mechanical/Production Engineering or at least 4 years experience and demonstrated skills
？ Statistics and Process capability
？ Project Management
？ English at a business level

强生（苏州）医疗器材有限公司诚聘