Quality Assurance Engineer - Product Development

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 global team, to be located remotely, we are looking for a:

Quality Assurance Engineer- Product Development

In this role as Quality Engineer you will support Novocure’s medical device product development activities by providing a technical review of design input requirements, design descriptions, and other product design and test documentation. This position involves frequent communication and coordination with Project Management, engineering and quality team members in Portsmouth NH, Switzerland, and Israel.

This is a full-time, remote position associated with our Poland office and reports to the Quality Assurance Manager, Product Development Quality.

Your responsibilities:

• Provide advice, guidance, and training as needed to ensure product realization activities and documentation meet quality system requirements
• Review engineering and test documents to ensure they meet Novocure quality system requirements consistent with applicable regulations, standards, and guidance
• Provide constructive feedback to improve design and test documentation
• Participate in product and process risk analysis activities
• Collaborate in requirements development and derivation
• Participate in corrective and preventative action activities
• Participate in design reviews

Your profile:

• BS in engineering or other scientific discipline with 7 years of working experience
• At least 2-5 years of experience in medical device product development preferred
• Demonstrated technical writing skills
• English language mastery and fluency
• Experience with risk analysis and risk management
• Experience writing and reviewing design input requirements
• Experience writing and reviewing design verification and validation protocols
• Critical thinking and decision making, including the ability to recognize when to ask questions
• Must have good written and oral communication skills
• Familiarity with Quality System Regulation, Medical Device Regulation, ISO 13485, and ISO 14971 is preferred

Benefits:

Financial

• Performance related bonus
• Life Insurance

Lifestyle

• Remote working
• Multisport card

Health

• Private Medical care