Jobdescription
We are looking for a Complaint Engineer 100% for oneof our clients in the canton of Neuchatel.
If youwant to work in a nice and dynamic environment in the medicaldevices industry then this position is made for you!
Contract type:open-ended temporary contract
Please note thisposition requires fluency in English andFrench.
Yourresponsibilities:
* Managecomplaint investigation: communication with intake service,decontamination process, complaint investigation (analysis inlaboratory, dimensional analysis, physical-chemical analysis, andany other necessary tests for product investigation and causeidentification), review risk files, identify root cause, DHRreview, report writing, archiving, escalation to NC or CAPA whenapplicable
* Implement andimprove procedures related to complaints in accordance withapplicableregulations/standards/requirements
* TrackCorrective/Preventive/ImprovementActions
* Participate toprojects related to complaintsactivities
* Raise awarenessamong other departments on complaintsprocessing
* Trackindicators
* Apply proceduresrelated to complaints and materialvigilance.
* Ensure adequateinvestigation of the complaints with relevant stakeholders(production, engineering, PD, QE,etc.)
* Review, approve andclose complaint investigations for LeLocle
* Implementation andmanagement of complaints procedures, investigation, trending, andproduct surveillance
* Performet review complaint trend analysis according to relevantGSOPs
* Management of HealthHazard Evaluation: complete documentation in coordination withrelevant stakeholders (Design Quality Assurance, Medical Safety,Product Development,
* PostmarketSurveillance)
* Participate toPost Market Surveillance activities : providedata
* Participate to riskmanagement analysis activities according to procedures and withinthe definedtimeline
* Participate andsupport internal audits and third party audits /inspections
Yourprofile:
* Minimum of BachelorsDegree is required, preferable in quality assurance, Engineering, aLife Science or a related technicaldiscipline.
* Minimum of 2years of professional work experience within a quality assurance orcompliance audit environment isrequired.
* Knowledge ofMedical device standards and regulations such as ISO13485, 93/42EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian,Japanese, Australian, Brazilian regulations,etc.
* Experience in a MedicalDevice manufacturing environment ispreferred.
* Training inlaboratory techniques inmedical
* Teamworkability
* Ability to interfacewith internal and externalcustomers
* Communication,organizational, negotiation and interpersonalskills
* Risk managementknowledge
* Root causeanalysis methods
* Fluent inEnglish and French
* Use ofMicrosoft office tools