Job Title

Job Description

You are responsible for

Compliance to Quality System

• Develops, when necessary local procedures or work instructions to comply with local regulations as well Philips quality management system
• Supports compliance of the commercial entity to the Philips quality system
• Coordinate and follow up CAPA implementation(s)
• Maintain the QMS and assist each function to set up related operational processes
• Assure GSP compliance of distribution centers: plan and coordinate external & internal periodic audits, including 3PL and supplier evaluations
• Track the audit/inspection findings and relevant corrective actions
• Collect, analyze and track relevant quality data
• Maintain and coordinate the quality training for the related functions, including the GSP training

Feedback Handling Management

• Manages & monitors the Philips customer feedback system including the receipt and subsequent closure of field related issue (per regulatory agency requirements when required). Provide the analysis report accordingly.
• Executes feedback review
• Screening for data consistency and quality check
• Ensure customer acknowledgement when necessary
• Assign local feedback owner according local rules
• Submit the feedback to the local feedback owner and the BU
• Ensures communication with BU’s with regard to adverse events reporting.
• Monitor feedback owners for tracking feedbacks from initiation to resolution in his/her assigned area
• Participates/supports feedback owner in designing customer communication

Adverse Event (AE) Handling

• Identify the reportable AE.
• Lead the cross-functional teams to work out proper report.
• Ensure all adverse events, which include local and oversea AE reporting are handled in timely manner and comply with regulation and Philips requirements.
• Perform Customer/Competent Authority communication.

Recall & Correction Management timely

• Lead the cross-functional team to handle all the recalls in timely manner
• Receives the BU Q&R communication and analyze it with the relevant people
• Tracks product recalls for Mandatory field change orders (FCOs) to closure.
• Ensure communication package localization
• Perform Customer/Competent Authority communication.
• Informs KM Post-Market Surveillance Officer on MA FCO completion and Competent Authority of his/her assigned countries.
• Ensure Philips Healthcare China to comply with all regulations requirements.

Post-Market Surveillance monitoring

• Responsible for PRER review and submission.
• Be the point of contact as quality partner for business unit (BU) to understand and anticipate BU’s quality needs and risks, and be accountable for quality activities of the BU (including but not limited to tough complaint case, regulatory inquiries.
• Ensures traceability and recording of all compulsory related data.

On Going Duties

• GSP license maintenance
• Responsible for updating tracking systems with local government
• Performs other related duties as assigned by management

You are a part of

Great China Q&R team

To succeed in this role, you should have the following skills and experience

• Bachelor degree or above, BS in Science or equivalent.
• Technical background is essential.
• Minimum of 5 years’ experience working in disciplined regulated industry.
• Experience with working with CFDA, Shanghai FDA is preferred.
• Rich experience in PMS affairs handling.
• Well understanding with ISO9001 and ISO13485 standards, knowledge of EU MDD and FDA QSR is an advantage.
• Family with China CFDA, CIQ, consuming products related regulations.
• Excellent communication and interpersonal skills.
• Positive attitude, will to take the lead for the responsible projects.
• Computer skills including database management, word processing and spreadsheets are also necessary.
• Good in written and spoken English and Mandarin

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.