Senior Technical Consultant

vor 4 Wochen


Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit

FSQ Experts GmbH is a leading provider of innovative solutions for medical technology companies. We offer precise and pragmatic support to overcome know-how or resource bottlenecks in quality management, regulatory affairs, and system engineering.

Our team of experts is dedicated to promoting a systematic approach for mastering complexity and contributing to the certification of safe medical devices. We manifest and expand a quality and safety culture in our customers' companies.

We are looking for a Senior Technical Consultant - Medical Devices to support the development of innovative and complex medical devices. The ideal candidate will have in-depth knowledge of product development, both in the V-model and in agile frameworks.

Key Responsibilities
  • Consult and engineer medical devices over the entire product lifecycle
  • Enable customers to comply with IEC 60601-x series and IEC 62304 standards
  • Contribute to the implementation of general safety and performance requirements in accordance with global medical device regulations
  • Coordinate and review technical documentation
  • Empower customer teams through technical advisory, process development, facilitation, or coaching
Requirements

Required qualifications and technical skills:

  • Relevant experience in technical consulting
  • Many years of involvement in medical device product development
  • Very good knowledge of HW and SW standards for medical devices
  • Risk-oriented mindset and prior knowledge of regulatory requirements worldwide
  • Familiarity with ISO 13485 and ISO 9001 quality management systems

Required soft skills and mindset:

  • Pragmatic, structured, communicative, and service-oriented
  • Curious and willing to contribute to expanding FSQ's knowledge base
  • Self-organized with excellent project and time management skills
  • Business fluent in German and English (at least level C1)
Benefits
  • Competitive salaries and performance-based bonus
  • Remote work and home office furnishings
  • Modern working equipment
  • Flexible working hours
  • A respectful way of working with each other
  • An open appreciative way of communicating
  • Part of a motivated team
  • A bright, agile, and modern company

We look forward to receiving your application (CV + motivation letter). Please let us know your earliest possible starting date and your salary expectations.



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