For one of our clients, medical device manufacturer based in Le Locle, we are looking for a Complaint Engineer for a 6 months TEMP contract.Your responsibilities :Manage complaint investigation: communication with intake service, decontamination process, complaint investigation (analysis in laboratory, dimensional analysis, physical chemical analysis, and any other necessary tests for product investigation and cause identification), review risk files, identify root cause, DHR review, report writing, archiving, escalation to NC or CAPA when applicableImplement and improve procedures related to complaints in accordance with applicable regulations/standards/requirementsTrack Corrective/Preventive/Improvement ActionsParticipate to projects related to complaints activitiesRaise awareness among other departments on complaints processingTrack indicatorsApply procedures related to complaints and material vigilance.Ensure adequate investigation of the complaints with relevant stakeholders (production, engineering, PD, QE, etc.)Review, approve and close complaint investigations.Implementation and management of complaints procedures, investigation, trending, and product surveillancePerform et review complaint trend analysis according to relevant GSOPsManagement of Health Hazard Evaluation: complete documentation in coordination with relevant stakeholders (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance)Participate to Post Market Surveillance activities : provide dataParticipate to risk management analysis activities according to procedures and within the defined timelineParticipate and support internal audits and third party audits / inspectionsYour profile :Minimum of Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline. Minimum of 2 years of professional work experience within a quality assurance or compliance audit environment is required. Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian, Japanese, Australian, Brazilian regulations, etc.Experience in a Medical Device manufacturing environment is preferred. Teamwork abilityAbility to interface with internal and external customers#LI MG1 #LI Hybridundefined