Senior Quality Analyst

Description

Job Summary: The Senior Quality Analyst is responsible for analyzing and documenting complaints, ensuring regulatory compliance and continuous improvement of the Tasy product quality and customer satisfaction. Key Highlights: 1. Accurate and precise analysis and documentation of complaints 2. Maintenance of detailed complaint records for post-market surveillance 3. Collaboration to ensure comprehensive data collection and compliance ### **Job Title** Senior Quality Analyst ### **Job Description** **Responsibilities:** • Works under direct supervision and in accordance with established operational processes and policies, analyzing and documenting complaints accurately and precisely, ensuring complete capture of relevant information and compliance with regulatory and organizational requirements. • Ensures maintenance of detailed complaint records, including investigation conclusions and resolution actions taken, to support post-market surveillance activities and facilitate continuous improvement initiatives aimed at enhancing the ***Tasy*** product quality and customer satisfaction. • Analyzes and evaluates complaint intake records from various channels to verify compliance with complaint definitions and regulatory requirements, performing duplicate checks to eliminate redundant records and ensure data accuracy and integrity in post-market surveillance activities. • Executes moderate Good-Faith Efforts (GFE) when necessary to collect additional data, supporting complaint evaluation and routing. Collaborates with relevant stakeholders to ensure comprehensive data collection in compliance with regulatory requirements and internal protocols. • Ensures appropriate coding application, reviews information entered into the complaint process, improves data organization and analysis, applies problem-coding to document the ***Tasy*** customer experience, and enables rapid resolution and generation of valuable insights to improve procedures and address recurring issues. * Identifies routine medium-complexity issues, determines whether escalation to a Level 2 or Level 3 investigator is required, and routes complaint records to a specialist or Complaint Operations Manager. * Follows internal follow-up procedures to obtain essential additional information needed to strengthen the investigation process, ensuring comprehensiveness and accuracy in analysis and decision-making. * Compiles records on various topics, presents them during the daily management review meeting, and ensures a comprehensive overview of relevant information for discussion and decision-making. • Prepares comprehensive investigation reports containing findings, conclusions, and actions taken; ensures accuracy and timeliness in maintaining complaint files and records to facilitate effective communication of investigation outcomes and support continuous improvement efforts. • Develops stable internal working relationships, exchanges standard information with colleagues, immediate supervisor, project leaders, and other team/group professionals. **Requirements:** * Bachelor’s degree completed; * Availability to work in a hybrid model at our Blumenau \- SC office; * Solid experience working in a regulated industry and document control tools, preferably in the healthcare sector; * Proficiency in Microsoft Office suite; * Experience in medical device or pharmaceutical industries will be considered a plus; * Prior experience with Tasy will be considered a plus; * Strong English reading and writing skills; **How We Work Together** We believe we generate greater impact when we are together rather than apart. For our office-based team members, this means working onsite at least **3 days per week** at our **Blumenau \- SC** office to collaborate and build connections with other team members.