
Quality Systems and Compliance Expert
2 days ago
You will act as functional support representing Quality as part of product development teams/projects.
Your focus will be on being the source of knowledge and expertise, bringing guidance and coaching/training on all aspects of Quality System Management and regulatory compliance.
You will also approve relevant documentation for cross-functional teams developing Software medical devices and health IT applications.
Key Responsibilities:
- Represent the Quality function in projects and processes.
- Responsible for promoting and where assigned, ensuring compliance to the quality management system and regulatory requirements.
- Responsible for escalation of possible compliance issues to the next level of the organization.
- Collaborate closely and communicate effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance.
- Support processes organization as per agreed assignments.
- Participate in the preparation and supporting external audits by coaching others, and/or as a guide and/or auditee.
- Participate in the preparation and performance of internal quality audits.
- Promote and maintain adherence to Elekta's values.
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