Lead PLM team to maintain and improve J&J product lifecycle quality management in JJMS as per ISO13485, J&J Quality Policy and regulatory requirements, focused on below items:
1.Maintain change control procedure for Product Lifecycle Management, and coordinate with cross functional team and source companies.
2. Lead team to setup and maintain the process and system for local adding Chinese IFU/Label and source flow specification. Ensure the system running per the requirement of procedure.
3. Lead team to setup and maintain the process to manage the artwork and specification of Chinese IFU/Label based on the compliance and quality perspective.
4. Support NPI and NID process.
5. Support Franchise CN label relocation and R&R council approval process for local labeling.
6. Manage and develop people and talent, to build a cohesive, high performing team.
7.Fulfill other tasks assigned.
1.Master or Bachelor Degree with at least 5 years’ experience in medical device, pharmaceutical, or related industry.
2.Medical Devices Quality Management System and Regulations Requirements in different National Regulation system, i.e. the QMS requirements of CFDA, FDA, EU, etc.
3.Necessary general and product relevant international / local standards, e.g. labeling and package relevant standards.
4.Basic experience in management of people and talents.
5.Having flowing experiences is a plus:
5.1.Experience in manufactory or labeling operation.
5.2.Experience in multi-industry.
5.3.Working experience in cross culture environment.
6.Skill Sets and/or Training and/or Certification for the Special Position
6.1.Ability to build collaboration and teamwork across functions.
6.2.Demonstrated project management skills with strong ability to negotiate and influence in a comprehensive environment. Certified project management skill is a plus.
6.3.Critical thinking and decision-making skills.。
6.4.Good communication skills and leadership.。
6.5.English fluent in reading, writing, speaking and listening.
6.6.Familiar with routine operations of computer and software.
Johnson & Johnson Medical Shanghai Ltd. (7055)Job Function
Quality (Eng)Requisition ID