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Medical Devices Quality Assurance Specialist
hace 2 meses
We are seeking a highly skilled and experienced Medical Devices Auditor to join our team at BSI Group. As a Medical Devices Auditor, you will be responsible for conducting audits of quality management systems to ensure compliance with regulatory requirements and industry standards.
Key Responsibilities- Conduct on-site, remote, or hybrid audits of quality management systems to assess compliance with ISO 9001, ISO 13485, and MDSAP standards.
- Develop and maintain strong relationships with clients to ensure their quality management systems meet regulatory requirements.
- Write comprehensive audit reports and provide recommendations for improvement.
- Collaborate with cross-functional teams to ensure effective implementation of audit findings and recommendations.
- Stay up-to-date with regulatory changes and industry developments to ensure expertise in medical devices and quality management systems.
- Minimum 4 years of hands-on experience in research and development, design, manufacturing, or servicing of medical devices.
- At least 2 years of experience working with quality management systems, including ISO 13485 and MDSAP.
- University or technical college degree or equivalent in a related STEM subject, such as biology, chemistry, computer science, or engineering.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with clients and colleagues.
- Strong analytical and problem-solving skills, with the ability to identify and address quality management system deficiencies.
BSI Group is a leading business improvement and standards company that helps organizations achieve excellence through the implementation of best practices and standards. With over 100 years of experience, BSI Group has a global presence and works with clients in over 193 countries. Our mission is to help organizations build trust and enhance lives by providing expertise in key industry sectors, including healthcare, automotive, aerospace, and more.
