Quality Complaint Specialist

Vor 5 Tagen

Lausanne, Waadt, Schweiz ONWARD Medical Vollzeit

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

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