Elekta is searching for a Director, Quality Assurance.
To ensure that processes needed for the quality management system throughout the area are established, implemented and maintained to enable product and services, defined strategies and policies, to meet the required standards and regulatory requirements in harmony with business needs.
To proactively identify continual improvement opportunities and direct improvement activities achieving improved efficacy and securing regulatory compliance in alignment with Elekta QA priorities and the business needs.
To work with the Regulatory Affairs function to ensure that the activities in the appointed area comply with existing and evolving regulatory, safety and quality system requirements.
To deploy and implement global quality policies and procedures into the Quality Management System, and to secure that local procedures are aligned and integrated accordingly.
Work with and secure that local distributors meets and follows the Elekta requirements in the appointed area.
A minimum of 8 years of Quality System or Quality Assurance management
Bachelor's Degree preferred
Experience with ISO compliance
Knowledge of FDA regulations and compliance
Previous experience with Quality Management in a Radiation Oncology or Medical Device environment preferred
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and t...echnology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives. Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta, a public company (OMX: EKTA B), employs around 3,400 employees globally. Please visit our website at www.elekta.com for more information.