Philips CH Vigilance Reporting Specialist 

China, Guangdong Province, Bao'an District 

41728006

CH and Vigilance Reporting Specialist

Your role:

• Analyzing complaint data, gathering additional data, as needed, and partnering cross functionally to share feedback to the development & manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints.
• Assess Risk assessment weather it is covering the hazard in the complaint
• Complete all needed records in a timely & accurate manner
• Confirming complaint condition & determining corrective action (including CAPA, FCO as required)
• Collaborate with cross functional team such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers & Manufacturing personnel to facilitate the complaint handling process globally.
• Evaluating & Investigating customer feedback, service records, and other sources of customer and internal for possible complaint.
• Evaluating incoming data & determine if it is sufficient to understand the nature of the complaint

You're the right fit if:

• Bachelor’s / Master’s degree in mechanical engineering, Bio Medical, Healthcare, Application Engineer, Nursing, or related technical degree with over 6 years (Medical device preferred) of experience.
• Hands on experience of Customer complaining experience in Medical industry is required, CAPA, Field Corrections as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820
• Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & Strong Analytical ability
• Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment
• Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies
• Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment
• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams
• Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have)

Personal Characteristics:

• Effective interpersonal, Communications & Excellent analytical skills
• Self-starter, quick learner, ability to work independently, disciplined, and meticulous in work activities
• Effective networking skills, detail oriented, ability to multitask through planning/organizing
• Demonstrate Philips behaviors consistently
• Excellent verbal, presentation, and written communication skills in Both Chinese and English
• Drive self-initiative to improve process