Complaints Handler

Job Summary

As Quality Complaint Specialist, you play a key role in patient safety by managing product complaints related to our medical devices in a timely manner and ensuring post market activities are well managed within the ONWARD organization.

Responsibilities

• Manage complaints within complaint team in accordance with the complaint handling procedure and in a timely manner, with the support of available software: register complaint, receive returned goods and decontaminate if necessary, investigate with relevant contributors to identify root causes, gather information, and recommend and follow solutions and corrective actions.
• Ensure reporting of serious incidents to the relevant authorities in a timely manner by providing necessary information to regulatory team and support early product surveillance investigations.
• Liaise with Customer Experience team to gather information and provide final response to complainants
• Document and manage complaint data and test results in global systems.
• Collaborate with cross-functional teams, including R&D, clinical affairs, and manufacturing, to address product safety and quality issues.
• Manage Device Deficiencies related to investigational devices (investigation, definition of CAPA)
• Contribute to management of feedback on investigational devices.
• Conduct statistical analyses to identify trends, drive quality improvements and support Post-Market Surveillance activities by gathering the relevant data and generating periodic reports.
• Identify areas for improvement and implement changes to enhance customer satisfaction.

Experience, Qualifications & Skills

• Bachelor's or Master's degree in life sciences or engineering.
• At least 5 years of relevant industry experience, particularly in the field of medical devices, and a solid. understanding of ISO quality management standards, ISO 13485, EU Medical Device Regulation (MDR), and FDA regulations.
• Experience in complaints handling and with methods used for Root Cause Analysis and problem solving.
• Demonstrate a strong affinity with the use of software tools to streamline quality processes and conduct statistical analysis.
• Experience with Salesforce and TrackWise Digital is a plus.
• Experience as an internal auditor is a plus.
• Exhibit an energetic, hands-on approach and enjoy working in an international, cross-functional environment, particularly within a dynamic and growing company.
• Excellent proficiency in English required; proficiency in French highly appreciated.
• ONWARD CODE Representation: Embody the core values of ONWARD.

Supervision

Individual Contributor

Compétences idéales

• Root Cause Analysis
• Salesforce

• Switzerland

Expérience professionnelle

• Other Healthcare

Compétences linguistiques

• English