Product Quality Engineer- Medical Technology/ISO 13458/GMP

Beschreibung

Product Quality Engineer- Medical Technology/ISO 13458/GMP/German

Project:
For our client a well-known pharmaceutical company in Central Switzerland we are looking for Product Quality Engineer.

Main Tasks:
-Assurance and verification of the product quality of the assigned products throughout the entire assembly and test chain-Specialist in manufacturing and testing processes in assembly and QC and 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 (e.g. trend analysis, statistical process control) as well as the corresponding meetings in the product team
-PQE representatives in the Product Team Meeting (PTM)
-Preparation of requirements for the test concept, the test planning and the test environment. Carrying out the classification of the required test and auxiliary equipment.
-Creation, update, review and training of specification documents, instructions and reports, as well as validation and qualification documents
-Responsible for the creation and updating of the pFMEA, test planning, test specifications in collaboration with affected departments
-Processing of specific CAPA and change tasks
-Identifies and presents improvement measures and implements them in consultation with the product team.
-Compliance and assurance of all Q-standards, guidelines, regulations and instructions as well as the safety and environmental protection requirements, Representation of QM regarding standard requirements

Secondary tasks:
-Professional 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 notifications Professional representation according to proxy list Job posting for providers.

Skills / Requirements:
-Experience in the regulated GxP environment ideally in medical technology (ISO 13458, GMP, FDA 21 CFR 820)
-You have a pronounced quality awareness and a structured, scientific approach is natural for you
-Technical flair and ideally understanding in dealing with test systems, test software and more complex Hard- and Software Architectures
-You appreciate independent and responsible work in a versatile product and project environment
-You are characterized by high teamwork, flexibility and resilience
-In-depth computer skills (MS Office, MiniTab, SAP, JMP)

Education:
-University or college degree in science / technology or laboratory with several years of project experience in the diagnostic or molecular biology laboratory

Language:
English - Advanced
German - Proficient

Reference no.: 918284SGR
Role: Product Quality Engineer- Medical Technology/ISO 13458/GMP/German
Industry: Pharmaceutical
Location: Lucerne und Region
Workload: 100%
Start: ASAP
Duration: 12++ months

If this position has aroused your interest, please send us your complete dossier via the link in this ad. If this position does not suit your profile so well and you wish to receive another position directly, you can also send us your dossier via this ad or to jobs [at] itcag [dot] com.
Contact us for more information about our company, our positions or our attractive payroll only program: .
About us:
ITech Consult is an ISO 9001: 2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of IT & Life Science candidates for contract work. Founded in 1997 by IT professionals, we know how important professional support is in finding and working with projects.