Aktuelle Jobs im Zusammenhang mit Quality Assurance Specialist - Lausanne, Waadt - ONWARD (GTX Medical)
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Quality Assurance Specialist
vor 2 Wochen
We are seeking a highly skilled Quality Complaint Specialist to join our team at ONWARD (GTX Medical). This individual will play a critical role in patient safety by managing product complaints related to our medical devices.
The successful candidate will be responsible for handling product complaints efficiently in accordance with internal procedures, including registering complaints, receiving and decontaminating returned goods (if necessary), investigating root causes with cross-functional teams, gathering relevant data, and recommending corrective actions.
This role also involves supporting the regulatory team by providing timely and accurate information for reporting serious incidents to relevant authorities and assisting with early product surveillance investigations.
In addition, the Quality Complaint Specialist will liaise with the Customer Experience team to gather information and provide final responses to complainants.
The individual will also 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, and contribute to management of Device Deficiencies related to investigational devices.
A Bachelor's or Master's degree in life sciences, engineering, or a related field is required, along with at least 2 years of industry experience in the field of medical devices and a solid understanding of ISO quality management standards, EU Medical Device Regulation (MDR), and FDA regulations.
Experience in complaints handling, root cause analysis, and problem-solving methodologies is essential. Proficiency in quality management software and statistical analysis tools is also required. Experience with Salesforce and TrackWise Digital is a plus, as is internal auditing experience.
The ideal candidate will possess a hands-on, proactive mindset with a collaborative approach, ability to work in a fast-paced, international environment, and excellent English proficiency, with French being highly appreciated. They must also represent the ONWARD Code: Empowered, Committed, Pragmatic, Innovative, Open, Trusting, Collaborative, and Passionate.
