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We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.
We currently have the following opportunity available - please contact us for more details!
The Quality Assurance Engineer within the Quality Management System function will support the development, implementation and monitoring of the Elekta Solutions quality system to maintain a compliant system towards applicable regulations & standards.
To be a source of knowledge, expertise, information, guidance and coaching on all aspects of Quality System Management. In particular provide expertise and support to the organization regarding quality assurance of suppliers.
Support the implementation of Elekta Quality Policy, other directives and processes throughout the Elekta Solutions quality system and organization.
Promote the quality system and its principles throughout the organization.
- Suggest and implement quality related process improvements.
Manage and perform internal audits.
Support external audits preparations and participate.
Support quality system non-conformities handling including local CAPAs.
Training of the organisation in the quality system.
Support activities in accordance with the RA & Q overall business plan and in alignment with the overall business objectives.
On behalf of direct manager approve quality system documentation.
On the behalf of direct manager approve non-conformances regarding process deviations.
On behalf of direct manager authorize changes to the Quality management system.
RELEVANT KNOWLEDGE, SKILLS AND COMPETENCIES
Quality Assurance and/or Regulatory Affairs management experience in the medical device or pharmaceutical manufacturing industry.
Objective driven and customer focused, with an ability to influence people.
Capable of producing results working unsupervised under own initiative.
A structured approach to problem solving with an appreciation of quality tools & techniques.
An effective team player who prefers to share and communicate problems and solutions with other members of the team.
Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
A positive attitude towards change to promote the global goals of the business.
High personal integrity.
A university technical degree or equivalent.
Good English written and verbal communication skills are essential.
Able to work within a multi-cultural environment.
Lead Auditor trained and knowledge of the European Medical Device regulation and US FDA regulations.