Supplier Quality Engineer

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 team in Krakow, Poland we are looking for an:

Supplier Quality Engineer

The Supplier Quality Engineer provides technical guidance and support to Novocure contract manufacturers and their suppliers in the areas of Medical Device Quality Assurance, Agreements, and Quality Control. This person ensures compliance to applicable regulatory requirements and procedures, while delivering to the objectives of applicable programs and strategic objectives. The Supplier Engineer Collaborates with business process owners and further develops product realization processes, ensuring stakeholder engagemect and an effective process framework facilitating rapid and cost effective delivery of safe and effective products.

Your responsibilities:

• Works with other members of the QA organization and Supply Chain to deliver against strategic goals and improvement plans
• Expands and improves the implementation of LEAN and Six Sigma methodologies both within Novocure and at its contract manufacturers and sub-tier suppliers.
• Acts and represents Supplier Quality as part of the Supplier Qualification process
• Ensure quality requirements are defined, implemented, maintained and monitored 
• Acts as QA approver for contract manufacturer and sub-tier supplier test plans, process changes, tooling changes, and specifications
• Ensure that for any deviation reported by Novocure (audit, complaint, NCMRs, others), a SCAR is efficiently implemented by the Supplier. If needed, support the supplier in the definition of the SCAR.
• For critical suppliers, conduct Monthly Quality Meetings to monitor Quality KPIs .
• Ensure compliance to Novocure applicable requirements
• Report performance of the process during quarterly quality meetings or others
• Conducts or support suppliers audits
• Specifics
• Travel requirement: 20%

Your profile:

• Minimum of a Bachelor degree, preferably in a Science or Engineering discipline, with applied Quality Engineering experience of 3-5 years
• Supplier and QMS auditing experience in medical device, pharmaceutical or comparably regulated field
• ISO 13485 Certified Lead Auditor is preferred
• LEAN Certification or demonstrated experience applying LEAN and six sigma principles and methodologies.
• Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines.
• Practical experience with Quality Risk Management, product lifecycle management (PLM) and process validation.
• Fluent in English both written and spoken; any further languages are of benefit

Benefits:

Financial

• Performance related bonus
• Life Insurance

Lifestyle

• Free fruit & cookies delivered for office staff
• Multisport card

Health

• Private Medical care

We are looking forward to receive your application to Natalia Kochanowicz, Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.