Description
Production Engineer- change management/GxP/SAP/German/EnglishProject / Role:
For our client in Rotkreuz we are looking for Production Engineer.
Background:
The Production Engineering teams are responsible for the implementation of technical change requests. To ensure that changes can be implemented smoothly, the individual steps of the change must be planned, the risk of the change must be estimated and justified, and the change must be verified/validated. This is done in close cooperation with the Quality Department.
Main Tasks:
Change management:
-Responsible for planning, coordination and implementation of changes in consultation with the Product Leader and/or Team Leader
-Performing assigned closing reviews of changes
Product:
-Participation in regular planning / status meetings in consultation with the product leader
-Technical assessment of amendments
-Technical assessment of the use of components and assemblies in case of transport damage
-Has in-depth knowledge of the assigned products
-Creation and maintenance of specification and verification documents for
Product manufacture:
-Creation and maintenance of routings, material master data and parts lists
-Execution of training courses on the production of specifications and verification documents for product manufacture as well as the preparation and coordination of the corresponding training certificate
-Cooperation in the preparation and revision of technical delivery conditions
-Support of the Technical Supplier Management and the production in error elimination and corrective actions
-Collaboration in the definition and procurement or modification of operating and auxiliary materials
Secondary tasks:
Quality management:
-Supporting CAPA activities and executing assigned tasks in the required quality and time frame
-For all tasks assigned to him, he is responsible for the qualitatively correct and goal-oriented execution in compliance with the deadlines.
-Adheres to the valid regulations, especially with regard to occupational safety, GxP and ISO 13485
-Technical examination of verification / validation documentation
-Maintenance of the knowledge database Wiki
-Participation in regular team meetings KVP / TOPinOPS (continuous improvement process)
-Technical support of defined improvement measures and documentation in change management
-Bringing in ideas to improve efficiency, safety, ergonomics in the entire working environment
-Permanent optimization of workflows and processes to increase quality and efficiency
-Active support in the implementation of improvement measures
-Project collaboration according to allocation
Must Haves:
-At least HF degree or comparable technical education/further training
-At least 2 years experience in change management
-At least 1 year of professional experience in medical technology in change management or at least 2 years of professional experience in change management, project or process management
-In-depth user knowledge in SAP or comparable ERP system
-Good user knowledge of the common Windows and Google applications
-Experience in the GxP environment ideally in medical technology (ISO 13458, FDA 21, CFR 820)
-You will be able to familiarise yourself quickly and efficiently in a complex working environment
-Team player, independent and reliable
Education:
-Solid educational background and experience of having worked in a similar position in an international environment
Nice to Haves:
-Project experience
-Pharma experience.
Languages:
- Fluent in spoken and written German
-English good written and spoken (documentation)
Reference-No.: 919545NC
Role: Production ENgineer
Location: Zug und Region, Schweiz
Workload: 100%.
Start Date: ASAP
Duration:12++ months
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.