Jobdescription
We are currently seeking a Quality engineer for oneof our clients in Canton of Neuchatel.
If you arelooking to work in a dynamic and very friendly working environmentand in the medical devices sector then this is foryou.
This is an open ended temporarycontract.
Please note this vacancy requiresfluency in French.
Yourresponsibilities:
* Ensuresthat adequate Quality support is provided to productions and toopen projects/initiatives
* Ensures thatNon Conformances are initiated, dispositioned, approved andinvestigated according to plans and in compliance with proceduresand regulatoryrequirements
* Ensures thatquality activities for validation of new processes/ products areperformed and documented according to procedures and within thedefined timeline
* Writeprotocols and reports for validation documentation (such as processvalidation, test method validation, validationplan..)
* Ensures that riskanalysis activities (PFMEA) are performed and documented accordingto procedures and within the definedtimeline
* Organize meetingfor risk analysis activities and write risk managementdocumentation
* Ensures thatGMP rules are known, understood and respected on thesite
* Ensure technicalsupport to QC and laboratorydepartment
* Escalates qualityissues and makes sure that appropriate actions are in place to fixthe issue in a compliantmanner
* Participates andsupports internal and third party audits /inspections
* Manages orparticipates to qualityprojects
* Provides support tocomplaint investigation ifrequired
* Participate toprocedure elaboration orupdate
* Ensures that CAPA aremanaged and documented according to plans and in compliance withprocedures
* Ensures supportto process improvementprojects
Yourprofile:
* A minimum of aBachelor Degree is required, preferable in Engineering, a LifeScience or a related technicaldiscipline.
* Experienceworking in a Medical Device manufacturing environment ispreferred.
* Fluent in Frenchand English
* Knowledge ofMedical device standards and regulations such as ISO13485, 93/42EEC, 21 CFR part 820
* Goodcommunication, organizational, negotiation and interpersonalskills
* Good analyticalproblem-solving skills.
* Useof Agile, Oracle, EtQ,Minitab
* Use of Microsoftoffice tools
* Good knowledgeof statisticaltechniques
Thoselines sound interesting ? We are looking forward to receiving yourapplication.