Product Quality Engineer -Six Sigma/Diagnostics
Posted on Feb 11, 2020 by ITech Consult
Product Quality Engineer -Six Sigma/Diagnostics/Quality Assurance (100%) Lucerne
We are looking for an experienced Product Quality Engineer who supports our consumables products in the product care phase for our customer for immediate employment (or by agreement).
Areas of responsibility:
* Constantly monitors and ensures the quality of the assigned products and carries out the professional approval of the assigned products. Specialist in test processes at the manufacturer and inspection center RDI. Knowledge carrier about manufacturing process, function of the consumables and its application in the instrument.
* Development and creation of test plans for product care activities (capacity expansion/transfer, etc.)
* Initialize test sample order, determine test scope, plan test, carry out DHR review.
* Data collection, data preparation and interpretation of test data during the manufacturing
* phase updates
* Creation and processing of deviation reports, including active support from the Consumables Manager,
* is the test equipment owner of test systems (from series production) and is responsible for calibration and maintenance of the equipment as well as the maintenance of the associated documents
* Creation of the maintenance instructions.
* Determining the scope of qualifications, planning and carrying out the qualification
* Writing and training the instructions, responsible for the correct use
* Responsible for the creation and implementation of deviation reports for faulty measuring equipment during calibration/maintenance or deviation reports during the production process, including risk analyzes
* Recognize error avoidance costs versus troubleshooting costs
* Additional tasks Review of the supplier documentation (test equipment qualification/test method
* validation) and creation and filing of the associated checklists Support in the coordination of validation
* projects in close cooperation with the disciplines of the Consumables Department and the consumables manufacturers Management or collaboration of projects and special tasks
* Creation, assistance or review of QAPs, SOPs, engineering studies, reports
* Processing change tasks/CAPA tasks
* Special checks Coordinate complaints, changes and deviations and their correct processing from Clarify. Assistance with budget planning and investments
* Support for the areas of development, consumables management, process support, procurement and quality assurance
* In-depth IT knowledge (MS Office, MiniTab, JMP or SAP)
* Experience in the regulated GxP environment, ideally medical technology (ISO 13458, GMP, FDA 21 CFR 820)
* Technical flair and ideally understanding in dealing with test systems, test software and complex hardware and software architectures
* 6 Sigma certificate (advantage)
* You appreciate independent and responsible work in a diverse product and project environment
* Professional experience in a GMP-compliant environment or clean room
* University degree or university of applied sciences in scientific/technical direction or laboratory assistant with at least three years of project experience in the diagnostic or molecular biological laboratory
* A good command of German (at least level B1/B2)
* English: (at least level B1/B2)
Reference No: 918905NC
Role: Product Quality Engineer
Industry sector: Pharma/IT
Location: Lucerne und Region, Switzerland
Start date: ASAP (or by arrangement)
Duration: 11 Months (strong possibility of extension)
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