Global Quality Internal Auditor
vor 2 Wochen
Location:
Root D4, CH, 6039Novocure 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, ovarian cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for a:Global Quality Internal Auditor
In this role as Global Quality Auditor you are responsible for conducting and following up on global internal audits as lead auditor.
You will support the internal audit teams, project teams and business partners to ensure compliance with company policies and procedures.
You will support the annual internal audit plan preparation and support training activities to increase quality awareness.Your responsibilities:
- Supporting Novocure inspection readiness and compliance
- Supporting Novocure Quality System Compliance and Inspection Readiness administrative activities
- Supporting quality improvement projects as defined by the manager
- In 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
Your profile:
- University degree or equivalent in engineering, scientific or related field in medical device or pharmaceutical field
- At least five 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 1901
- Sound knowledge of interpretation and implementation of ISO 13485, FDA 21CFR 820, MDR and MDSAP
- Excellent written and oral communication skills
- Fluent in English and preferably German, both written and spoken
- Proficient in Microsoft Office
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