Healthcare - Complaint Handling Unit Engineer

Department/Group: Quality and Regulatory Department
Address: Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industry Park, Suzhou, Jiangsu Province,

JOB DESCRIPTION

Main purpose of the role
• 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 and ISO13485 7.2.3
• Handling complaints from Installed Base, and adverse event reporting.
• Creating Field Action document package and performing Field action reporting to Marketing Authority in time.

Organisation context of role
a. Products/services:
• Products are image diagnostic medical device, such as CT, MR, DXR, ultrasonic, and their components and accessary.
• Setting up quality system is the foundation for a medical device company to start operation. Also compliance to regulatory agencies’ requirements is the must for a medical device company to stay in business.
b. Position in value chain:
• 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
c. Other relevant organisational aspects: (e.g. diversity of the business; acquisitions/ventures; geographical spread; risk; dynamics of the organisation and market; the complexity of the technologies used; the innovation of the products, etc. etc.).
• Philips Healthcare (Suzhou) Co., Ltd is a brand new facility therefore a new QMS needs to be in place to support that.
• We focus on the China Domestic market, but also provide products to international markets.

Reporting and other significant organisational relationships
• Reporting Relationship: Sr. Quality System Manager
• Peers: : Mainly the Q&R team and Q&R colleagues in other BUs across IS business group.
• Other significant relationships – internal: Complaint review board, adverse event report review board, and field action review board, Internal quality system audit meetings, Cross functional improvement meetings, defect tracking meetings, CAPA
• Other significant relationships – external: Customer Audit, Notified body (TUV) audit, China CFDA and US FDA inspections

Key areas of accountability
• 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

Job Holder’s Profile Requirements
• BS/MS in Engineering or equivalent experience
• Strong quality assurance management experience, minimum 5 years
• Strong Post Market surveillance and experience
• 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