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  • Medical Devices Auditor

    hace 3 semanas


    Madrid, Madrid, España Bsi Group A tiempo completo

    Job SummaryWe are seeking a highly skilled Medical Devices Auditor to join our team at BSI. As a Medical Devices Auditor, you will be responsible for conducting audits of quality management systems to ensure compliance with regulatory requirements. This is a field-based role, with 70-75% of travel required within EMEA.Key ResponsibilitiesConduct audits of...

Medical Devices Quality Assurance Specialist

hace 2 meses


Madrid, Madrid, España The British Standards Institution (BSI) A tiempo completo

About the Role:

We are seeking a highly skilled Medical Devices Auditor to join our team at The British Standards Institution (BSI). 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:

  1. Conduct on-site, remote, or hybrid audits of medical devices manufacturers to assess their quality management systems.
  2. Write detailed audit reports and provide recommendations for improvement.
  3. Liaise with clients and internal stakeholders to manage audit schedules and ensure timely completion of audits.
  4. Stay up-to-date with regulatory requirements and industry standards, including ISO 13485, MDSAP, and MDR.

Requirements:

  1. Minimum 4 years of hands-on experience in research and development, design, manufacturing, or servicing of medical devices.
  2. Experience working with quality management systems, including ISO 13485 and MDSAP.
  3. Strong understanding of medical device regulations, including MDR and ISO 13485.
  4. Excellent communication and interpersonal skills.
  5. Ability to work independently and as part of a team.

Preferred Qualifications:

  1. University or technical college degree in a related STEM subject, such as biology, chemistry, computer science, or engineering.
  2. Professional certifications, such as CQI or IRCA, are a plus.

About BSI:

BSI is a global leader in standards and compliance solutions. We help organizations navigate complex regulatory landscapes and improve their performance through certification, training, and advisory services. As a Medical Devices Auditor at BSI, you will be part of a dynamic team that is passionate about delivering excellence in quality and safety.