Quality Assurance Lead
2 days ago
We are seeking a highly skilled Senior Quality Assurance Engineer to join our Regulatory Affairs & Quality Team. As a key member of our team, you will play a crucial role in ensuring the highest quality standards for our medical devices and health IT applications.
In this exciting and diverse role, you will be responsible for promoting and ensuring compliance with our quality management system and regulatory requirements. You will also represent Quality on internal management meetings, projects, and analyse responses on governing agency actions.
- 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.
Key Responsibilities:
- Compliance-related activities such as internal and external quality audits, nonconformance/concession/CAPA management, training of the organization in the quality system.
- Improving and developing ways of working and QMS procedures together with other functions.
About You:
- Experience and training in regulatory affairs, quality management systems, and/or Engineering within a medical device environment.
- Training and/or experience in relevant medical device regulations and standards, e.g. EU MDR, QSR, ISO 13485, MDSAP, ISO 14971, IEC 62304.
- A university degree in Engineering or equivalent in a related field.
- Experience in design and development and risk management, preferably including experience from projects involving medical device software.
- Strong English written and verbal communication skills.
- Able to work within a multicultural environment.
What We Offer:
- Opportunity to work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care.
- International innovative team and opportunities to learn and develop.
- Hybrid work option (you are required to work on location at least 3 days/week).
Hiring Process:
We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, genetic information, national origin, disability, veteran status, or any other status protected by law in the locations where Elekta operates.
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