Quality System Engineer

Novocureis 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 a: Quality System Engineer

JOB SUMMARY:

You will provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as Medical Device Regulation, ISO13485 & FDA, MDSAP, MDR requirements and applicable laws. You will define and ensure the quality requirements in improvement projects and initiatives in cross-functional teams within organization. You will act as point of contact for quality-related questions in the context of audits - both external and internal.  You will play a key role in monitoring of quality data and metrics to ensure appropriate investigation, corrective and preventive actions, and/or escalation is conducted as required for recurring trends. You will analyze process, product, test, and Quality Management System data in terms of improvement opportunities and support handling of issues and CAPAs. 

RESPONSIBILITIES:

• Supporting Novocure inspection readiness and compliance
• Collaborate on risk analysis and pFMEAs in the course of the Quality Management System
• Providing support in definition of requirements for quality improvement initiatives
• Ensure activities comply with the applicable Novocure Quality System requirements and external requirements
• In time delivery regarding assigned tasks and project deliverables
• Ensuring the compliance of Novocure Quality Management System and related documentation
• Supporting via administrative activities the Novocure Quality System Compliance and Inspection Readiness

YOUR PROFILE:

Qualifications:  

• Scientific Degree in a Medical, Pharmaceutical, Biotechnological, or related field 
• Training evidence for Quality Management System Standards and Regulations

Knowledge:

• About 1-2 years of experience in similar position in medical device or pharmaceutical field
• General Knowledge of medical devices industry
• Experienced in terms of law and legislations as well as corresponding regulations, norms and standards in pharmaceutical or medical device field
• Knowledge of ISO13485, FDA 21CFR, MDD/MDR standards for Medical Devices and preferably MDSAP
• Able to work in an international team environment and execute tasks with minimal direct supervision
• High degree of attention to details and general culture of quality
• Very good communication skills and stakeholder management skills
• Proficient in English, both written and spoken
• Proficient in Microsoft Office
• Knowledge of EDMS and QMS systems would be an advantage

Benefits:
•    Performance related bonus
•    Life Insurance 
•    Free fruit & cookies delivered for office staff
•    Multisport card 
•    Private Medical care

...and more!

We are looking forward to receive your application to Emilia Bagińska, Senior Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com.