Complaint Handling Specialist

6 days ago


Dongguan, Guangdong, China Philips Full time

Job Title: CH and Vigilance Reporting Specialist

Job Summary:

We are seeking a highly skilled Complaint Handling Specialist to join our team at Philips. As a key member of our Vigilance Reporting team, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities:

  • Analyze complaint data, gather additional information as needed, and collaborate with cross-functional teams to share feedback with development and manufacturing teams on potential product improvements, product defects, and safety evaluations.
  • Assess risk and determine whether the hazard is covered in the complaint.
  • Complete all necessary records in a timely and accurate manner.
  • Confirm complaint conditions and determine corrective actions, including CAPA and FCO as required.
  • Collaborate with cross-functional teams, including Engineers, Scientists, Clinical Specialists, Field Service, and Application Engineers, to facilitate the complaint handling process globally.
  • Evaluate and investigate customer feedback, service records, and other sources of customer and internal data for possible complaints.
  • Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint.

Requirements:

  • Bachelor's or Master's degree in mechanical engineering, biomedical, healthcare, application engineering, nursing, or a related technical field with over 6 years of experience in the medical device industry.
  • Hands-on experience in customer complaint handling, CAPA, field corrections, and global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820.
  • Hands-on experience in problem-solving methodology and root cause analysis, 7 QC tools, problem-solving, and strong analytical ability.
  • Demonstrated ability to self-motivate, prioritize tasks in a deadline-driven environment, and work effectively with various work groups to ensure conformance to regulatory requirements, internal processes, and policies.
  • Demonstrated ability to work effectively with others in various coordinated disciplines and on multi-national teams.
  • Applied understanding of GDP, ISO 9001, and ISO (good to have).

Personal Characteristics:

  • Effective interpersonal, communication, and 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 processes.

What We Offer:

As a Complaint Handling Specialist at Philips, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality medical devices. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.



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