NCMR Coordinator

Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers. 

To support our team in Root, Switzerland we are looking for a

NCMR Coordinator – Quality Engineer

In this role as NCMR Coordinator you are responsible for the NCMR process. The NCMR coordinator is responsible for the review, management, and processing of the nonconformance reports generated in the Quality System, to address quality issues or disposition of products. The NCMR Coordinator is also responsible for the continuous improvement of the NCMR process and procedures, granting that the users are implementing the requirements accurately and precisely and are following the prescriptions of the relevant NCMR SOPs.

The function will regularly provide information to the LT and other functions about the status of the NCMRs, trending of them, aging and other KPIs which may be established to improve the overall quality levels in Operations.

Your responsibilities:

Reviews, manages, approves, monitors and trends the Non Conformances and the Quality Issues generated by the organization, providing technical and compliance guidance. Performs analysis to assess quality and meaning of data Collaborate with other functions to create reports with performance indicators to identify and correct quality problems Using statistical tools identifies, analyzes, and interprets patterns and trends in complex data sets that could be helpful for the diagnosis and prediction of Quality Issues Prepares reports for the management stating trends, patterns, and predictions using relevant data Works with engineers and management heads to identify process improvement opportunities, propose system modifications. Participates to internal audit program Assist as an SME during external audits

Your profile:

University degree in a scientific discipline or related Engineer/Science qualification (Minimum BSc and preferably Electronics or Data Analytics) with a minimum of 3 years working as a quality engineer in a multi-national medical device manufacturing & distribution environment. Proficiency in statistics and statistical packages is desirable Knowledge of data visualization software like Tableau, PowerBI, etc. is desirable Profound knowledge of SAP and BOBJ is a must Working knowledge of the FDA medical device Quality Systems Regulations. Prefer a solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, MDD). Working knowledge and experience on NCMR Management Adept at queries, writing reports, and making presentations Strong knowledge of quality system regulations. Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience. Excellent English

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