Supplier Quality Engineer

Jobdescription

We are currently seeking a Supplier Quality Engineerfor one of our clients in Canton of Neuchatel.

Ifyou are looking to work in a dynamic and very friendly workingenvironment and in the medical devices sector then this is foryou.

This is an open-ended temporarycontract

Please note this vacancy requiresfluency in French.

Yourresponsibilities :

Providesquality assurance leadership to select contract manufacturing sitesand raw material suppliers engaged in the production of Integraproducts

Establishes andensures the Approved Supplier List is up todate

Establishes timelyplanning and execution of supplieraudits

Conducts SupplierAudits according to good manufacturing practices, ISO Standards,and applicable regulatoryrequirements

Ensurescomprehensive measurement systems in place to monitor supplierquality / reliability, and to identify, correct and preventdefects

Establish and ensureSupplier Quality Agreements are up to date for applicable suppliersengaged in the production of Integraproducts

Report on contractmanufacturer performancemetrics

Ensure technicalsupport to QC, purchasing and productiondepartments

Provide QualityEngineering Support to suppliers including audits / assessments,inspection technique support, verification / validation activities,CAPA and change management. FDA CFR part 820 and ISO 13485regulations / standards will be thefocus.

Addresses SupplierChange Requests in compliance with procedures and regulatoryrequirements.

Ensures thatactivities for validation of outsourced processes / products areperformed and documented according to procedures and within thedefined timeline.

Ensuresthat Supplier Non-conformances are initiated, dispositioned,approved and investigated according to plans and in compliance withprocedures and regulatoryrequirements.

Escalatesupplier quality issues to management as appropriate, develop andpropose robust and compliantsolutions.

Participates inand leads continuous improvement projects andinitiatives.

Participatesand supports internal and third-party audits / inspections.

Manages orparticipates in quality projects asrequired.

Provides supportwith complaint investigations asrequired.

Yourprofile :

A minimum of aBachelor’s Degree in an Engineering, Life Science, or a relatedtechnical discipline is required. Candidates with an equivalentcombination of education and experience will also be considered forthe position.

Experienceworking in a Medical Device manufacturing environment ispreferred.

Operationssupplier quality experience ispreferred

Minimum 3 years ofprofessional work experience in a GMP and / or ISOregulated

industry isrequired

Knowledge ofMedical device standards and regulations such as ISO13485,93 / 42

EEC, 21 CFR part820

Auditing background isrequired

Lead Auditorcertification to ISO 13485 : 2016 stronglypreferred

Strongcommunication, teamwork, and organizational skills areessential

Strong analyticalproblem solving and root cause analysisskills

Use of ERP, PLMsystems

Use of Microsoftoffice tools

Knowledge ofstatisticaltechniques

Experience orknowledge with the machining processes, injection molding, and / orelectro-mechanical components / assembly ispreferred

Willingness totravel as part ofduties

Fluent in French andEnglish