Quality System Engineer

Quality System Engineer ,  Location: Cracow, hybrid (3 days office, 2 days home office)

Full time role, permanent position (contract of employment)

At Novocure, every role contributes to extending the lives of people living with cancer. 

As Quality System Engineer 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 a cross-functional teams with other departments such as Clinical Operations, DSS or others. 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 on a regular basis 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. 

What You’ll Do

• Supporting Novocure inspection readiness and compliance
• Collaborating on risk analyses and process Failure Mode and Effects Analyses (pFMEAs) within the Quality Management System
• Contributing to the improvement of the Quality Management System by reviewing, updating or creating Quality System Documents

• Preparation of Quality Management Plans and coordination of process Change Controls
• Providing support during internal audits, as well as audits conducted by notified bodies, customers, and regulatory authorities, including follow-up on audit observations
• Supporting the resolution and management of Issues/Deviations and Corrective and Preventive Actions (CAPAs)
• Assisting in defining requirements for quality improvement initiatives, interdisciplinary projects
• Supporting improvement initiatives in cross-functional teams
• Ensuring all activities are compliant with applicable Novocure Quality System requirements and external regulations
• Delivering assigned tasks and project deliverables within established timelines

About You:

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

• About 4+ years of experience in similar position in medical device or pharmaceutical field
• General Knowledge of medical devices
• 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
• Knowlegde of EDMS and QMS systems would be an advantage

About us

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you’ll connect, grow, and make a real difference. We’re a company with the drive of a startup and the strength that comes with 25 years of success.

Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers.

What We Offer

The annual base salary ranges from 180 000-210 000 PLN gross per annum.

This pay range is the range of base pay compensation within which Novocure expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated.

This job includes the following benefits:

• Performance related bonus
• Life Insurance
• Multisport card/Benefit system
• Private Medical care
• ..and more!

Novoflex – our trust-based hybrid work philosophy

We offer a flexible, trust-based hybrid working model for our office-based roles. Employees are asked to be in the office an average of three days per week, with the flexibility to choose which days work best for them. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early, starting late, or working fewer days occasionally, we trust you to balance your time in a way that works for both you and Novocure.

Ready to Apply?

If you're excited about this role please apply. You might be just the person we’re looking for!