CAPA Specialist
Novocure is a global medical device company with R&D based in Haifa. The company is growing quickly as it commercializes TTFields therapy: a novel treatment for aggressive cancers using alternating electric fields.
As part of the effort to extend Novocure’s Quality Assurance department, we are looking for a CAPA specialist, who will Participates in the implementation and maintenance of the CAPA process within the Quality Management System, to meet all internal and regulatory requirements.
The CAPA specialist works closely with other functional areas to ensure CAPA-related activities and documentation are managed in a complete, clear, concise, and controlled manner.
This is a full-time position, located at our R&D center, Haifa, Israel.
This role reports to the CAPA Manager
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Supports local and global functions in the management of their CAPAs
- Coordinates CAPA review meetings, tracks and follows up with action items.
- Ensures all investigations are written according to the CAPA policies and procedures.
- Assists in developing CAPA training content and provides CAPA training as required
- Facilitates the Root Cause Investigation and Action Plan processes
- Ensures compliance to ISO13485 and other applicable medical device standards and regulations
QUALIFICATIONS/ KNOWLEDGE:
Qualifications:
- Associate Degree in the Engineering, Life Sciences, or related areas.
Knowledge:
- Minimum 2 years’ experience in the Manufacturing, Quality or Engineering industries.
- Ability to solve problems and utilize analytical skills
- Excellent collaboration and communication skills
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience
- Ability to prioritize and manage several tasks simultaneously
- English proficiency in reading, writing, and speaking – a must.
- Familiarity with regulations, standards, and guidance for medical devices - advantage
ABOUT NOVOCURE:
Our vision
Patient-forward: aspiring to make a difference in cancer.
Our patient-forward mission
Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
Our patient-forward values
– innovation
– focus
– drive
– courage
– trust
– empathy
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