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