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Medical Devices Quality Assurance Specialist

hace 2 meses

Madrid, Madrid, España Bsi Companies A tiempo completo
About the Role

We are seeking a highly skilled and experienced Medical Devices Auditor to join our team at BSI Companies. 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 medical devices and equipment to assess quality management systems
  • Write detailed reports and provide recommendations for improvement
  • Liaise with clients and internal stakeholders to manage audit schedules and client relationships
  • Participate in training and development programs to enhance skills and knowledge
  • Collaborate with cross-functional teams to ensure effective implementation of audit findings
Requirements
  • Minimum 4 years of hands-on experience in research and development, design, servicing, maintenance, testing, manufacturing, or production of medical devices
  • Experience working with quality management systems, including ISO 13485 and MDSAP
  • Strong understanding of regulatory requirements and industry standards for medical devices
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
What We Offer
  • Opportunity to work with a global leader in standards and compliance
  • Competitive salary and benefits package
  • Professional development and training opportunities
  • Collaborative and dynamic work environment