Quality System Engineer - Continuous Improvement

Date: Jul 9, 2024

Location: PL

Company: novocure

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:

Quality System Engineer

 

Provide guidance to project teams and business partners to ensure compliance with company policies and medical device regulations, and support improvement initiatives across various departments. Collaborate on risk analysis and pFMEAs, and serve as a contact for quality-related questions during audits. Monitor quality data regularly to identify improvement opportunities and support handling of issues and CAPAs, while also contributing to the development of the management system and process design.

 

Your responsibilities:

  • 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
  • Collaborate on risk analysis and pFMEAs in the course of the Quality Management System
  • Contact for quality-related questions in the context of audits by notified bodies, customers and authorities
  • Support internal audits as well as follow-up of audits performed by notified bodies, customers and authorities
  • Participation in the further development of the management system and in process design, according to all applicable standards, regulations and law
  • Supporting Novocure inspection readiness and compliance
  • Ensuring the compliance of Novocure Quality Management System and related documentation

 

Your profile:

  • Training evidence for Quality Management System Standards and Regulations
  • At least 1-2 years of experience in similar position in medical device or pharmaceutical field
  • Experienced in terms of local law and legislations as well as corresponding regulations, norms and standards in pharmaceutical or medical device field
  • Proficient in Microsoft Office
  • Good written and oral communication skills in English as the primary language will be Polish
  • High degree of attention to details and general culture of quality
  • Knowledge of ISO 13485, FDA 21CFR, MDD/MDR standards for Medical Devices and preferably MDSAP

 

 

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.