For our client specialized in medical devices, localized in the French part of Switzerland, we are looking for a :

Post Market Surveillance Specialist

Your mission
Monitor complaint activity and support operation and maintenance of the Quality Management System to meet compliance programs in accordance with MDD/MDR, IVD/IVDR, ISO 13485.

Your responsibilities

Collaborate with relevant departments and stakeholders to investigate non-conformities, defects and product failures
Manage complaints customer
Asses potential safety issues and vigilance system
Manage incident reports
Manage quality activities pertaining to the Non-Conforming Events (NCE) and Corrective/Preventive Actions (CAPA) for non-manufacturing locations, which includes the control, segregation, labeling and disposition of non-conforming or suspected non-conforming materials at European Technical Center
Provide oversight of the European Technical Center, implementing necessary corrective actions to ensure that operations comply with company policies and procedures
Perform regular inspections and assessments of sub-contracted activities, including European Technical Center
Coordinate and partner with different departments (Field Service, Sales, Marketing, Quality, Customer Support, Production) to help appropriately resolve customer issues and product defects at European Service Center
Review and analyze trends from data and summarize appropriately. Provide reports for applicable quality meetings
Create and maintain department procedures as required
Provide contribution in problem solving efforts on selected projects to improve process and overall quality outcome
Adhere to and follow internal policies and procedures and apply function-related SOP requirements

Your profile

Minimum bachelor degree in Sciences, Healthcare or Engineering
Minimum a 5-year experience in medical devices company
Fluent in English
Experience in quality audit would be a plus

Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay.