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George Town

    Specialist II, Product Surveillance - George Town, Malaysia - Abbott

    Abbott
    Abbott George Town, Malaysia

    Found in: Talent MY C2 - 1 day ago

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    Description

    MAIN RESPONSIBILITIES

  • Product Surveillance Analyst is responsible for Medical Device Report (MDR) submission documentation and follow-ups, and will include interaction with Complaint Coordinators, Failure Analysis, Servicing, Customer Service, etc.
  • Performs all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering).
  • Analyzes and resolves customers technical and clinical questions regarding company products.
  • Corresponds with customers regarding the results of inquiries and analysis of products.
  • Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer complaints.
  • Participates in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues.
  • This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints.
  • Ensures accurate department procedures and work instructions are maintained
  • Train new employees to the complaint handling process
  • Provide support to the Legal Department regarding product complaints
  • Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross functional complaint teams, new product teams, risk management meetings

    • QUALIFICATIONS

    Education

  • Bachelor's Degree preferably in clinical / Medical / Scientific discipline or equivalent.

    • Experience/Background

  • Knowledge in Medical Terminology is fundamental to the role.
  • Average of 1-2 years in customer support or complaint handling experience would be advantage to this position.
  • Strong PC/Data Entry Skills required.
  • A high degree of interpersonal relations skills, with strong verbal and written communication skills in English language.
  • Good Problem-Solving Skills: Must be able to work under pressure and stress common to office environments; maintain a high degree of accuracy and analytical thinking; and with ability to deal effectively with problems and customers on the telephone.
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