Jobdescription
We are currently seeking a Senior Quality Systemengineer for one of our clients in Canton ofNeuchatel.
If you are looking to work in adynamic and very friendly working environment and in the medicaldevices sector then this is for you.
This is anopen ended temporary contract.
Please note thisvacancy requires fluency inFrench.
Yourresponsibilities:
QMS:
* Participateto procedure creation andupdate
* Ensures GMP, GDPrules are known, understood and respected in thesite
* Ensure Quality Systemsupport to alldepartments
* Escalatesquality issues and makes sure that appropriate actions are in placeto fix the issue ina
* compliantmanner.
* Manages orparticipates to qualityprojects
CAPA:
* Actas CAPA Process Owner
* EnsureCAPAs are managed in compliance with internal procedures as well asapplicable standards
* Followup CAPA process and ensure CAPA are handled and documentedadequately
* Ensure Auditprocess support to alldepartments
AUDIT:
* Participatesand supports internal and third party audits /inspections
* Perform internalaudits
* Ensure internal Auditplanning is implemented and followup
* Ensure Audit processsupport to alldepartments
QUALITYPLAN:
* Ensure QP are managedin compliance with internal procedures as well as applicablestandards
* Participates andsupports the QPprocess
* Ensure QP process isimplemented and followup
* KPI,QMR
* Ensure KPI and QMR arehandled in compliance with internal procedures as well asapplicable
* standards
* Participatesand supports the KPI, QMRprocess
* Ensure QP process isimplemented and followup
Yourprofile:
* A minimum of aBachelor Degree is required, preferable in Engineering, a LifeScience or a related technicaldiscipline.
* MinimumExperience of 5 years working in a Medical Device manufacturingenvironment ispreferred.
* Fluent in Frenchand English
* Knowledge ofMedical device standards and regulations such as ISO13485, 93/42EEC, EUMDR 2017/47, 21 CFR part820
* Good communication,organizational, negotiation and interpersonalskills
* Good analyticalproblem-solving skills.
* Useof Agile, Oracle, EtQ,TWD
* Use of Microsoft officetools
* Good knowledge ofstatisticaltechniques
Thoselines sound interesting ? We are looking forward to receiving yourapplication.