Product Quality Engineer:- PQE/QC Testing and Assembly/pFMEA

Posted on Dec 9, 2018 by ITech Consult

Luzern, Luzern Switzerland
Research & Development
7 Jan 2019
Annual Salary

Product Quality Engineer:- PQE/QC Testing and Assembly/pFMEA/CAPA/Medical Technology/

Project/Role: For our customer, a renowned pharmaceutical company in Central Switzerland, we are looking for an experienced Product Quality Engineer as soon as possible. The role is contract position for 12 months (with strong possibility of extension) close to Lucerne, Switzerland.

Main Tasks:
-Ensuring and checking the product quality of the assigned products throughout the entire assembly and testing chain
-Specialist in manufacturing and testing processes in assembly and QC as well as coordinator between QA, R&D HW and SW, GCS, Technical Support, PQE QC Testing and Assembly
-Responsible for the evaluation and analysis of quality data (eg trend analysis, statistical process control) as well as the management of corresponding meetings in the product team - PQE representative in the Product Team Meeting (PTM)
-Creation of requirements for the test concept, the test planning and the test environment. Execution of the classification of the required test and auxiliary equipment.
-Preparation, updating, review and training of standard documents, instructions and reports as well as validation and qualification documents
-Responsible for the creation and updating of pFMEA, test planning, test specifications in collaboration with affected departments
-Processing of specific CAPA and Change Tasks - Identification and presentation of improvement measures and implementation in consultation with the product team
-Compliance with and assurance of all quality standards, guidelines, regulations and instructions as well as the safety and environmental protection specifications, representation of the QM with regard to standard requirements

Secondary tasks:
-Technical release of the assigned products as well as troubleshooting and technical support during release tests in the QC.
-Processing, technical review and risk assessment of deviation reports Technical substitution according to the list of substitutes.

-Good experience in the regulated GxP environment, ideally medical technology (ISO 13458, GMP, FDA 21 CFR 820)
-Should have a pronounced quality awareness and a structured, scientific approach is a matter of course for you.
-Good technically and good understanding of test systems, test software and complex hardware and software architectures.
-Should be willing to work independently and responsibly in a versatile product and project environment.
-Should be a good team player, flexible and able to work under pressure and have very good communication skills in German and English (spoken and written).
-In-depth IT knowledge (MS Office, MiniTab, SAP, JMP)

-University or technical college degree in natural sciences/technology or laboratory assistant with several years of project experience in diagnostic or molecular biological laboratories.

-German - Proficient
-English - Advanced

Reference No.: 917914NC
Role: Product Quality Engineer
Industry: Medical
Location: Luzern und Region
Workload: 100%
Start: 01.01.2019
Duration: 12 months+

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.

About us: ITech Consult is a certified ISO 9001:2008 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.

Reference: 597230336

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