Global Quality Internal Auditor

Global Quality Internal Auditor,  Location: Cracow, hybrid

Full time role, permanent position (contract of employment)

At Novocure, every role contributes to extending the lives of people living with cancer. 

As the Global Quality Internal Auditor you will plan, conduct, and follow up global internal audits as lead auditor, support annual internal audit plan preparation, and support internal audit teams. In this role you will support training activities to increase quality awareness in relation to audits including creation of training material, review and approval of relevant documents, updating corresponding procedures, and conduct related classroom trainings. You will act as point of contact for quality-related questions in the context of audits by notified bodies, customers and authorities.  You will deputize Quality Assurance Engineers and take over relevant activities based on need.

This is an exempt, full time role tied to the Krakow office and reporting to the Senior Manager, Governance and Quality Culture.

What You’ll Do

• Supporting Novocure inspection readiness and compliance.
• Supporting Novocure Quality System Compliance and lnspection Readiness administrative activities.
• Supporting quality improvement projects as defined by the manager.
• Providing guidance to project teams and business partners to ensure compliance with the company policies and procedures as well as MDR, ISO 13485, FDA 21 CFR part 820 and MDSAP requirements and applicable laws.
• ln time delivery regarding assigned tasks and responsibilities.
• Fulfilling duties and responsibilities in line with the Quality Objectives and Goals.
• Ensure activities comply with the applicable Novocure Quality System requirements and external requirements.
• Ensuring the compliance of Novocure Quality Management System and related documentation.
• Acting in accordance with Novocure's Code of Conduct.
• Following up on audits performed by notified bodies, customers and authorities.
• Participation in the further development of the quality management system according to applicable standards, regulations and law.
• Monitoring the quality data and metrics on a regular basis to ensure appropriate investigation, corrective and preventive actions, and/or escalation is conducted as required for recurring trends.
• Analyzing process-, product-, test-, and Quality Management System data in terms of improvement opportunities.
• Collaborating on risk analysis and pFMEAs in the course of the Quality Management System.
• Support handling of issues and CAPAs.
• As assigned, contributing to updates or creation of Quality System Documents.
• Supporting the line manager as required and advised in the daily business activities and audit related initiatives.

About You:

• University degree or equivalent in engineering, scientific or related field in medical device or pharmaceutical field.
• About 5+ years’ practical experience in similar position.
• Qualification(s) and experience as an auditor.
• Experience with QMS requirements for medical devices (preferred), or similar strong regulated areas like pharma.
• Experience in Quality Assurance (preferred for medical devices).
• Sound knowledge of ISO 19011.

• Sound knowledge of interpretation and implementation of ISO 13485, FDA 21CFR 820, MDR and MDSAP.
• Excellent written and oral communication skills.
• Excellent organizational and time management skills.
• Fluent in English both written and spoken.
• Able to work in a team environment and execute tasks with minimal direct supervision.
• High degree of attention to details and general culture of quality.
• Proficient in Microsoft Office.
• Willingness to travel (about 20-40%)

About us

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you’ll connect, grow, and make a real difference. We’re a company with the drive of a startup and the strength that comes with 25 years of success.

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 work 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.

What We Offer

The annual base salary ranges from 144 000-186 000 PLN gross per annum.

This pay range is the range of base pay compensation within which Novocure expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated.

This job includes the following benefits:

• Performance related bonus
• Life Insurance
• Multisport card/Benefit system
• Private Medical care
• ..and more!

Novoflex – our trust-based hybrid work philosophy

We offer a flexible, trust-based hybrid working model for our office-based roles. Employees are asked to be in the office an average of three days per week, with the flexibility to choose which days work best for them. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early, starting late, or working fewer days occasionally, we trust you to balance your time in a way that works for both you and Novocure.

Ready to Apply?

If you're excited about this role please apply. You might be just the person we’re looking for!