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Regional Product Quality Specialist - Medical Device

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Regional Product Quality Specialist - Medical Device

  • Location:


  • Sector:

    Monroe Hospital & Healthcare

  • Job type:


  • Salary:


  • Contact:

    Narrtiyanee Nani

  • Contact email:

  • Job ref:


  • Published:

    27 days ago

  • Expiry date:


  • Client:

    Monroe Consulting Group

Executive Recruitment Company Monroe Consulting Group Malaysia's Healthcare Division is recruiting on behalf of a well-known Medical Device company seeking an energetic and ambitious Regional Product Quality Specialist (Remote Job) with a background in healthcare to utilize product technical knowledge, communication skills, and business expertise to provide internal and external customers with effective communication and technical support for assigned product areas.

Job Responsibilities

  • Strive to provide top-notch product information, including details about attributes, materials, composition, and usage, to both internal and external healthcare customers.
  • In charge of receiving, filing, documenting, and routing all complaints regarding product deficiencies & Minor Products Business Unit via the electronic Complaint System.
  • Acts as the primary contact for customers who encounter product quality issues and concerns.
  • Responsible for conducting due diligence when gathering information requested by investigation units, which includes evaluating product samples and assessing potentially reportable events within the established timeframe.
  • Held accountable for ensuring that outgoing external communications meet Company standards for regulatory, legal, and marketing correspondence.
  • Support the global implementation of new products and solutions that meet and exceed customer requirements.
  • Conduct periodic technical data reviews and suggest improvements for the complaint handling process and enterprise management tools.
  • Deliver ongoing complaint handling compliance training to the Internal team.
  • Act as the established subject matter expert in providing complaint handling system support for all team members.
  • Offer suggestions for system enhancements and take part in testing aspects of the complaint handling system as needed.
  • Record contact information and maintain accurate and complete records that comply with internal requirements and meet local, domestic, and international regulatory and government requirements.
  • Lead the development and communication of policy and procedure documentation related to complaint handling.


  • Holding Bachelor Degree in Science or related.
  • Minimum 3 years of relevant working experience.
  • Liaise with different regions with customers/clients (Regional Experience)
  • Good Communication skills especially in English.
  • Good in clinical knowledge.