长沙招聘

Position: PMS Complaint Specialist

Location: Shanghai

• Your challenge
  Evaluate, investigate, track and complete complaints through effective and established complaint handling process.
  
  Duties and responsibilities include:

• Work to develop and improve the complaint handling process while maintaining compliance with all FDA regulations.

• Support internal and external audits.

• Team work is embraced and highly regarded. Enforce and comply with the Philips Quality processes.

• Evaluate complaints in a timely manner for the need to investigate.

• Identify product characteristics and/or failures that could lead to a death or serious injury

• Review and code complaints to provide trending information necessary for Product Quality Monitoring.

• Assist product investigators in determining and identify potential systemic product issues.

• Provide proper verbiage and trending information on each complaint to ensure FDA compliance.

• Develop and maintain support systems knowledge including SAP, Clarify, OneEMS and Trackwise.

• Utilize creative problem solving techniques.

• Consistently being available to support our team in meeting all business objectives.
  
  Requirements:
  
  Education: Bachelor degree, major in engineering discipline or equivalent is preferred.

• Experience: At least 3 years of Quality and/or Regulatory experience in medical or highly regulated industries, experience in Post-market Surveillance is an advantage.

• Competencies and skills:

• Good command of English and Chinese Language skill is required.

• Demonstrated strong results orientation.

• Proficiency using statistical tools, office tools, and various other computer software applications.

• Must be able to work under pressure to meet regulatory reporting timeframe and company requirements.

• Be willing to work outside of normal working hours as needed to accommodate businesses in multiple time zones.

• Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment

• Requires the proven ability to consistently meet and/or exceed goals.

• Must be capable of making commitments, setting priorities, and delivering results on time.

• Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives

  
  
  

   

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