Position: Mid-Senior level

Job type: Full-time

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Job content

Responsibilities

:
  • Support and enable our business partners regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility.
  • Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
  • Quality responsibility for
  • Documents: Support business partners, review and approve documents, templates and records to ensure product quality and compliance
  • Change management: Support business partners, review and approve changes to ensure product quality and compliance
  • Deviation management: Support business partners, review and approve deviations to ensure product quality and compliance
  • Process Risks: Support business partners, review and approve pFMEA to ensure product quality and compliance
  • Support special projects or initiatives in the area of Quality and business partners
  • Permanently optimize processes in order to increase quality and efficiency standards
Must Haves
  • Technical or scientific degree or completed education in a technical profession.
  • At Least 3 years professional experience with the medical device regulations including ISO 13485 and FDA regulations for the above mentioned processes
  • At least 3 years professional experience with working in process improvement projects
  • Solid experience with quality management
  • Solid experience in a demanding interface role in a complex environment, good stakeholder management skills across all hierarchy levels to ensure a successful communication
  • Very good German language skills (B2 or higher) and good English verbal and written language skills
  • experience of bringing MES to production is a plus
  • Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.
  • solution oriented mindset
  • self-dependent, structured, quality oriented and determined
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Deadline: 10-05-2024

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