In this role, you have the opportunity to
Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed.
Concentrate on CFR820.198 complaint files, 820.803 MEDICAL DEVICE REPORTING, 820.806 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS, ISO13485, ISO14971 and global regulation’s requirement.
Handling complaints from Installed Base, and adverse event reporting.
Creating Field Action document package and performing Field action reporting to Marketing Authority in time.
You are responsible for
Responsible for customer complain handling by interface with field service
Drive the customer complaint resolve by working with cross functions
Responsible for adverse event reporting to applicable Authority Competency
Evaluate the risk level with R&D team for complaint hazardous situation per Product Risk Management Files
Drive Complaint process and implementation
Issue field action document package with LCM team, and perform the field action reporting to competency authority.
Organize Complaint periodic review and work with cross function to facilitate Complaint closure
Organize Quality Training and conduct quality training as needed
Support QMS manager to promote Quality Culture
Quality statistic, Analysis and process improvement
You are a part of
Internal: major functions such as R&D, manufacturing, purchasing etc
External: regulatory agencies such as US FDA, China CFDA and notify bodies such as TUV
To succeed in this role, you should have the following skills and experience
BS/MS in Engineering or equivalent experience
Strong quality assurance management experience, minimum 8 years
Strong Post Market surveillance and experience, including complaint handling, field action, adverse event reporting.
Strong statistical and analytical abilities.
Six Sigma Black Belt is preferred
Image System Product service experience is preferred
Strong communication, problems solving and continuous improvement.
Fluent English both in writing and speaking.
Have experience in medical industry is plus
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 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .