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Quality Assurance Specialist for Medical Devices
hace 1 mes
We are seeking a talented Quality Assurance Specialist to join our team in Spain, with a strong focus on medical devices. The role involves traveling throughout EMEA, conducting quality management system assessments to ensure patient safety and regulatory compliance.
Job Overview
In this position, you will work closely with our team to assess quality management systems, providing expertise on standards such as ISO 9001 and ISO 13485, as well as schemes like MDSAP and UKCA/CE marking. You will also support conformity assessment activities related to medical device regulations. Your responsibilities will include:
• Conducting on-site, remote, or hybrid audits independently or as part of a team
• Writing detailed reports and collaborating with the planning team to manage client relationships and audit schedules
• Completing administrative tasks as required
Requirements
To succeed in this role, you must have a minimum of four years' hands-on experience in areas such as research and development, design, manufacturing, or servicing. Your experience should cover a range of medical devices, including active devices, IVD instrumentation, and orthopaedics. Additionally, you must have at least two years' experience working with quality management systems and hold a degree in a related STEM field, such as biology, chemistry, computer science, or engineering. A bachelor's, master's, or doctoral degree is essential.
About Us
The British Standards Institution (BSI) is a global partner for companies and organizations worldwide, with over 100 years of experience in setting standards. We are headquartered in London and operate in over 193 countries. As a Quality Assurance Specialist, you will be an integral part of our team, contributing to the excellence of our services. If you share our passion for delivering high-quality results and want to be part of a dynamic team, apply now
