In this role, you have the opportunity to
Act as a confident advisor on approval, regulatory compliance, and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
- Act as a Project Manager with internal CAPA owners to manage all aspects of CAPA activities which include gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
- Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions, and effectiveness checks.
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
- Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
- Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency Represent CAPAs during audits and CAPA Review Board meetings.
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
You are a part of
- You will additionally support site Q&R in Shanghai. your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance, and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience
- Total more than 5 yrs. Work experience in quality functions, experience with CAPA is required; experience in Medical/automotive related industry is preferred.
- Able to understand and analyze complex problems, including software and hardware design issues.
- Demonstrated deep knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations,
- Work knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
- Strong Project Management skills, including ability to project manage all CAPA activities.
- Ability to analyze data and apply statistical techniques.
- Ability to assess risk as it pertains to the CAPA
- Excellent written and verbal communication skills both Chinese and English
- Interface in manufacturing and design change process including process audits, process verification and validation audits
- Quality Engineering responsibilities including Preview, review, and approval of Design History File, engineering change orders, product/process validation and verification protocols/reports
- Participate and review design control activity
- Responsible to support and be knowledgeable of business specific standards
- Manage activities within the CAPA process. Manage workflow in the CAPA process.
- Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead CAPA activities, and provide assistance in other Quality areas, as needed
- Maintain a high level of expertise in current regulatory root cause investigation requirements, and serve as a resource for compliance to these requirements.
- Maintains current knowledge of applicable national and international regulations, acts as a consultant to other departments.
In return, we offer you
We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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