Risk and Validation Quality Engineer- Medical Devices

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.

Novocure Poland is our newest office in Europe and you will be part of a global business services team supporting multiple business functions including finance and payroll and located in Krakow. The global business services organization within Novocure Poland is critical to Novocure’s efforts to drive process efficiency, standardizations and drive greater business value as the company prepares for future growth.

To support our team in Krakow, Poland we are looking for an:

Risk and Validation Quality Engineer

The primary responsibilities include managing quality aspects of Novocure’s process and equipment validation programs.  Ensure validation programs meet requirements of FDA and ISO, and process compliance. Along with the execution and planning of internal and external validations, this position will also be responsible and accountable for the execution of the requirements related to the Risk Management activities. This position will maintain and regularly update the pFMEA and relevant documentation, identifying the risks and proposing/implementing mitigations.This position will also support internal audits at specified intervals and report audit findings, promote continuous improvement of systems, products, and services.

Your responsibilities:

• Responsible for creation of high level test plans, oversee its progress and completion
• Responsible to review and approve test methods, validation test plans and results.
• Responsible for Validation samples management
• Act as a point of contact for subcontractor test laboratories
• Participate and support Novocure Global PM program implementation (SW)
• Conduct of internal audits per annual program
• Relevant Issue/NCMR/CAPA management

Your profile:

• University degree in a scientific discipline or related Engineer/Science qualification (Minimum BSc and preferably Electronics) with a minimum of 3 years working as a quality engineer in a multi-national medical device manufacturing & distribution environment.
• Proficient with qualification / validation of test methods and manufacturing processes including equipment used for validation/ verification/manufacturing.
• Proficient in utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, etc). A Six Sigma certification will constitute a preferential title.
• Proficient in planning and overseeing execution of product validation studies (pharma and/or medical device industry experience is a must).
• Application of quality regulations and standards (21CFR 820, ISO 13485, MDR is preferred).
• Excellent English, as the primary working language

Benefits:

Financial

• Performance related bonus
• Life Insurance

Lifestyle

• Free fruit & cookies delivered for office staff
• Multisport card

Health

• Private Medical care

We are looking forward to receive your application to Natalia Kochanowicz, Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.