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Quality Manager R&D Team Lead

vor 2 Monaten


Hamburg, Hamburg, Deutschland seca Vollzeit

About the Role:

We are seeking a highly motivated and experienced Quality Manager R&D Team Lead to join our team at seca. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest quality and precision in our medical devices.

Key Responsibilities:

  • Lead a cross-functional team of specialists in technical documentation, user manuals (IFU), and Technical Files.
  • Develop and implement a directive for MDR-compliant project documentation, including training, consulting, and ensuring compliance.
  • Adapt existing processes to meet regulatory requirements, streamlining processes where possible.
  • Advise R&D project leaders (PL) and Product Owners (PO) on applicable norms and provide support with understanding issues.
  • Plan and conduct internal audits within the R&D department, including addressing any deviations.
  • Ensure knowledge transfer of new employees in the area of medical devices and MDR-compliant documentation for successful auditing.
  • Prepare and accompany R&D-related certification audits and other external audits to ensure successful execution.
  • Closely coordinate with the Quality Management Representative (QMR) from the Quality Assurance department and report directly to the Head of R&D.

Requirements:

  • Relevant experience in quality management at an industrial company, preferably in the medical technology sector.
  • Experience with the requirements for compliant development documentation according to MDR.
  • Excellent knowledge of ISO 13485 and 21 CFR Part 820.
  • Desirable: Experience in interpreting the standard ISO 62366: Usability for Medical Devices.
  • Experience in document creation and control.
  • Responsibility and a high level of initiative and coordination skills.
  • Excellent German and English language skills in writing and speaking.

About seca:

seca is a leading international company in the medical technology sector. We are a family-owned business with a long history of success and a strong commitment to quality and innovation. Our company culture values teamwork, professionalism, and a passion for delivering exceptional results.

What We Offer:

  • A competitive salary and benefits package.
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A comprehensive onboarding program to ensure a smooth transition into the role.