Quality Complaint Specialist

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Quality Complaint Specialist

At ONWARD we're looking for a Quality Complaint Specialist to join our team.
Full-time · Lausanne

About the job

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.

About you

  • 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.

Apply for the job

Do you want to join our team as our new Quality Complaint Specialist? Then we'd love to hear about you!