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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 device manufacturers to assess their quality management systems and ensure compliance with regulatory requirements and industry standards.
  2. Develop and maintain strong relationships with clients to ensure their quality management systems meet regulatory requirements and industry standards.
  3. Provide expert guidance and support to clients to help them improve their quality management systems and ensure compliance with regulatory requirements and industry standards.
  4. Collaborate with cross-functional teams to develop and implement audit plans, conduct audits, and provide audit reports.
  5. Stay up-to-date with regulatory requirements and industry standards related to medical devices and provide training and guidance to clients as needed.

Requirements:

  1. Minimum of 4 years of hands-on experience in one or more of the following areas: research and development, design or design development, servicing, maintenance, and testing, manufacturing or production experience.
  2. Experience working with quality management systems, including ISO 13485 and MDSAP.
  3. Strong knowledge of regulatory requirements and industry standards related to medical devices, including ISO 9001 and MDR.
  4. Excellent communication and interpersonal skills, with the ability to build strong relationships with clients and colleagues.
  5. Ability to work independently and as part of a team, with a strong attention to detail and ability to meet deadlines.

Education:

  1. University or technical college degree or equivalent in a related STEM subject, such as biology, chemistry, computer and software technology, electrical, electronic, mechanical, or bioengineering, human physiology, medicine, pharmacy, physics, or biophysics.

About BSI:

BSI is a global partner for 86,000 companies and organizations in over 193 countries. We are a leading provider of standards, testing, and certification services, and we are committed to helping organizations improve their performance and achieve their goals.