Complaint Handling Specialist

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About the role

Job Title Complaint Handling Specialist Job Description Job title: Complaint Handling Specialist Your role: The PMS Complaint Handling Specialist 40 is responsible for providing support and coordination in managing complaints by facilitating communication, analyzing processes, escalating issues, collaborating with stakeholders, documenting findings, and ensuring compliance with regulatory standards for efficient post-market surveillance operations. The role involves providing information on product-specific concerns and supporting communication with complaint evaluators and investigators. The role includes documenting and evaluating the complaint handling process for continuous improvement. The role identifies escalation points in basic complaints and participates in team meetings for insights and error documentation. You're the right fit if: (4 x bullets max) 1. Experience: Must to have 5+ of medtech industry experience 2. Skills: • Works under direct supervision and established processes and operational policies meticulously, provides information on basic product-specific concerns, supports responding to questions from complaint evaluators and complaint investigators, ensuring effective communication and support throughout the process. • Applies analytical skills to efficiently resolve routine requests, impacts their own work results with limited influence on the team, and adheres to established processes and operational policies to achieve objectives and meet deadlines effectively. • Records the quality of the complaint handling process executed by both the complaint evaluator and complaint investigator, assists in implementing ongoing evaluation and improvement measures to enhance performance and effectiveness in managing complaints. • Assists in reviewing basic complaints, identifies instances requiring escalation, particularly regarding initial coding assessment, product inquiries, and reportability decisions and addresses routine inquiries about products. • Participates in team meetings, contributes insights, and updates, meticulously documents errors for comprehensive analysis and improvement and facilitates the identification of patterns and areas for enhancement. • Ensures comprehensive documentation by logging all complaints into the complaint management system, capturing every relevant detail to facilitate thorough analysis and resolution and supporting effective communication and decision-making in department. • Follows up with customers to confirm their complaints are resolved and satisfactory, and coordinates with external vendors or service providers for complaints involving third-party services or products. • Compiles complaint data comprehensively, gathers additional information as necessary, and collaborates cross-functionally to provide constructive feedback regarding potential product enhancements, defects, and safety evaluations. • Aids in documenting service records meticulously, applies precise and suitable coding, categorizes services records as per coding, enhancing data integrity, enabling comprehensive analysis and informed actions, and ensuring accuracy and relevance as an essential input to the overall process. • Utilizes a basic knowledge of regulations, requirements, and standards to efficiently execute tasks within the realm of post-market surveillance complaint operations, ensuring adherence to regulatory mandates and facilitating effective management and resolution of complaints. 3. Education: Bachelor's degree in any Engineering 4. Anything else: • Post-Market Surveillance Mechanisms • Quality Management Systems (QMS) • Quality Specifications • Data Analysis & Interpretation • Regulatory Requirements • Technical Documentation • CAPA Methodologies • Continuous Improvement • Complaint

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