Risk and Validation Engineer

Risk and Validation Engineer

Miejsce pracy: Kraków

Your responsibilities

• Plan, coordinate, and oversee validation activities for manufacturing processes, equipment, and test methods.
• Create and review validation documentation, including test plans, protocols, reports, and test methods.
• Manage validation samples and coordinate activities with external testing laboratories.
• Maintain and update product risk management documentation, including Process Failure Mode and Effects Analysis (pFMEA), identifying risks and implementing appropriate mitigation actions.
• Support the implementation and maintenance of global preventive maintenance programs.
• Conduct internal quality audits in accordance with the annual audit program and support follow-up activities.
• Manage quality issues, including non-conformances (NCMRs) and CAPAs, ensuring timely investigation and resolution.
• Collaborate with cross-functional teams to ensure compliance with internal quality standards and regulatory requirements.
• Contribute to continuous improvement initiatives that strengthen quality systems, products, and manufacturing processes.
• Support calibration and preventive maintenance activities for measuring devices and test equipment, as required.

Our requirements

• Bachelor's degree in Engineering, Electronics, Life Sciences, or another relevant scientific discipline.
• Around 3+ years of experience as a Quality Engineer within the medical device, pharmaceutical, or other highly regulated manufacturing environment.
• Hands-on experience with process, equipment, or test method validation.
• Good understanding of quality management systems and medical device regulations, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and MDR.
• Experience with risk management methodologies such as FMEA and Root Cause Analysis.
• Knowledge of quality tools, statistical techniques, Six Sigma, or similar methodologies would be an advantage.
• Strong analytical thinking and attention to detail.
• Excellent organizational and project management skills, with the ability to manage multiple priorities.
• Strong communication skills and the ability to work effectively with cross-functional and international teams.
• Excellent written and spoken English.

What we offer

• Novoflex – our trust-based hybrid work philosophy
• Flexible hybrid working model for office-based roles
• Trust in managing your schedule to balance life and work
• Performance Bonus
• Life Insurance
• Multisport card/Benefit system
• Private Medical Care

Benefits

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• life insurance
• remote work opportunities
• flexible working time
• fruits
• integration events

Recruitment stages

• Application
• Review
• Interview

NOVOCURE POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer.

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 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.