Senior Quality System Analyst
强生（苏州）医疗器材有限公司
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2013-12-17
- 工作地点：苏州
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：体系工程师/审核员
职位描述
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
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
公司介绍
强生（苏州）医疗器材有限公司诚聘