Quality Complaint Specialist
At ONWARD we're looking for a Quality Complaint Specialist to join our team.
Full-time · Lausanne
Quality Complaint Specialist
As a Quality Complaint Specialist, you play a critical role in patient safety by managing product complaints related to our medical devices. You will ensure timely resolution and contribute to post-market surveillance, helping maintain high-quality standards within ONWARD.
Responsibilities
Handle product complaints efficiently in accordance with internal procedures. This includes registering complaints, receiving and decontaminating returned goods (if necessary), investigating root causes with cross-functional teams, gathering relevant data, and recommending corrective actions.
Support the regulatory team by providing timely and accurate information for reporting serious incidents to relevant authorities and assist with 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.
Work closely with R&D, Clinical Affairs, and Manufacturing teams to resolve product quality and safety concerns.
Contribute to management of 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, including PSUR report.
Identify opportunities for enhancing customer satisfaction and refining complaint-handling processes.
Bachelor's or master degree in life sciences, engineering or related field.
At least 2 years of industry experience 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, root cause analysis and problem-solving methodologies.
Proficiency in quality management software and statistical analysis tools.
Experience with Salesforce and TrackWise Digital is a plus.
Internal auditing experience is a plus.
Hands-on, proactive mindset with a collaborative approach.
Ability to work in a fast-paced, international environment.
Excellent English proficiency: French is highly appreciated.
Represent the ONWARD Code: Empowered, Committed, Pragmatic, Innovative, Open, Trusting, Collaborative and Passionate.
Supervision
Individual Contributor reporting to our Senior Quality Assurance & EHS Manager.
Do you want to join our team as our new Quality Complaint Specialist? Then we'd love to hear about you!