Novocure is looking for a Quality System Engineer to provide guidance to project teams and business partners, ensuring compliance with company policies, Medical Device Regulation, ISO13485, FDA, MDSAP, and MDR requirements. You will define quality requirements in improvement projects, act as a point of contact for audits, and monitor quality data and metrics to drive appropriate investigations.
What You'll Do
- Support Novocure inspection readiness and compliance
- Collaborate on risk analyses and process Failure Mode and Effects Analyses (pFMEAs) within the Quality Management System
- Contribute to improving the Quality Management System by reviewing, updating, or creating Quality System Documents
- Prepare Quality Management Plans and coordinate process Change Controls
- Provide support during internal audits, as well as audits by notified bodies, customers, and regulatory authorities, including follow-up on audit observations
- Support the resolution and management of Issues/Deviations and Corrective and Preventive Actions (CAPAs)
- Assist in defining requirements for quality improvement initiatives and interdisciplinary projects
- Support improvement initiatives in cross-functional teams
- Ensure all activities comply with applicable Novocure Quality System requirements and external regulations
- Deliver assigned tasks and project deliverables within established timelines
What We're Looking For
- 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 a similar position in the medical device or pharmaceutical field
- General knowledge of medical devices
- Experience with law, legislation, regulations, norms, and standards in the 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 detail and a general culture of quality
- Very good communication and stakeholder management skills
- Proficient in English, both written and spoken
- Proficient in Microsoft Office
Nice to Have
- Knowledge of EDMS and QMS systems would be an advantage
Technical Stack
- Microsoft Office
Team & Environment
You will work collaboratively in cross-functional teams with departments such as Clinical Operations and DSS, supported by a team of passionate and innovative colleagues.
Benefits & Compensation
- Performance related bonus
- Life Insurance
- Multisport card/Benefit system
- Private Medical care
- Compensation: 180,000-210,000 PLN gross per annum
Work Mode
This is a hybrid position based in Cracow.
Novocure is an equal opportunity employer.
