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.
- 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.