Quality Management Systems Expert
7 days ago
About the Role
We are seeking a highly skilled Medical Devices Auditor to join our EIMEA Medical Devices Auditing Team. As a Medical Devices Auditor, you will be responsible for ensuring the quality and safety of medical devices, particularly those with high-risk software.
Key Responsibilities
- Conduct audits of medical devices to ensure compliance with ISO 13485 and other relevant standards
- Assess the technical expertise of medical devices, including research and design, validation, testing, and servicing
- Work with cross-functional teams to identify and mitigate risks associated with high-risk software
- Develop and implement effective quality management systems to ensure patient safety and timely market access
Requirements
- Technical expertise in high-risk software medical devices, including research and design, validation, testing, and servicing
- Working experience of quality management systems and understanding of ISO standards, particularly ISO 13485
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment and prioritize multiple tasks
What We Offer
- 27 days annual leave, paid sick leave, and bank holidays
- Health insurance, life insurance, and pension plan with company contribution
- Car allowance (dependent on role), income protection, paid maternity leave, paid paternity leave, paid parental leave, adoption leave, compassionate leave, and paid bereavement leave
- Learning and development opportunities, and a wide range of flexible benefits
About BSI
BSI is a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services. We are a Notified body with a history spanning over a century and are committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate.
Our Values
- Client-centric
- Agile
- Collaborative
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