The world market leader in In vitro-Diagnostics in Rotkreuz (ZG), is looking for a highly motivated team player with GMP knowledge and first touchpoints with deviation and change management
As an MSAT Engineer within the Manufacturing Science & Technology (MSAT) Engineering Team for our Blood Gas and Electrolyte (BG/E) sensors operations, you will provide scientific support to running BG/E operations. Your experience, analytical approach and know-how will be crucial to support deviation handling and product release, driving investigations and identifying process improvements to ensure the continuous compliance, quality and supply of our blood gas products. This position is for the project support of the NMPA Project. The NMPA project takes care that BG/E Ops is compliant with the regulations from NMPA. The NMPA (National Medical Product Administration) supervises the safety of drugs, medical devices and cosmetics sold in China. Furthermore, it organizes the drafting of laws and regulations, formulates normative documents, and supervise the implementation thereof. That means that (BG/E) Ops needs to comply to these documents.
- Deviation-, change- and document management in SAP (process/equipment)
- Key participant in the manufacturing problem solving process to ensure a fact based and data driven root cause analysis and counter measure identification
- Ensure compliance status through thorough documentation and timely actions in collaboration with QA
- Adopt & optimize production processes to improve quality, increase yield and lower cost for the respective products
- Be a key player in establishing, maintaining and continuously improving control loops for the respective products
- Degree in Natural Science or Engineering or apprenticeship with experience in a related field
- > 3 years professional experience in a manufacturing company and/or first experience in deviation and change management (GMP knowledge!)
- Inspired to learn manufacturing technologies and continuously improve diverse BG&E processes with a hands-on approach to support our in-house production efficiently
- First experiences with qualification and validation, SAP or Mandarin language are of advantage
- Fluent in English and good knowledge of German (verbal and written)
Please apply online. For further information about the position, please contact your Kelly consultant, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07/ +41 76 310 760 9)
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