Quality Manager / Engineer

AVVie GmbH

Mar 8th, 2023

AVVie is an exciting early-stage medical device company with innovative, minimally invasive technology for the treatment of mitral valve disease.

Tasks

Roll & Responsibilities

The candidate will provide guidance and support on quality requirements to AVVie during the design, prototype, and development phases of a Mitral Butterfly Implant.

Main responsibility is to implement and maintain a QMS and support the R&D team with all quality-related issues.

  • Implement and maintain quality management system (ISO 13485 & US FDA QSR) in cooperation with external consultant
  • Compiling of documentation and integration into internal QM system
  • Actively stays current with external and internal quality system standards and requirements (ISO 13485, ISO 14971, and other applicable standards)
  • Develop, implement and maintain the company’s risk management processes
  • Ensuring compliance to design control procedures
  • Preparation and monitoring of trainings
  • Assists in coordination and management of all internal, supplier and external audits
  • Providing support in identifying deficiencies in quality systems, defining and implementing systematic improvements
  • Drive project activities to ensure timely completion of quality-related project milestones

Requirements

Requirements:

  • Degree in Mechanical Engineering, Biomedical Engineering, or related disciplines
  • Minimum of 3 years of related experience (Quality Systems Engineer) within the medical device industry (Class III medical devices)
  • Prior experience in setting up a QMS in the medical device environment
  • Deep practical knowledge of ISO 13485 and ISO 14971 requirements
  • Experience with ISO 10555 is a plus
  • Experience in a production environment is a plus
  • Interested in supporting the development of an innovative structural heart concept
  • Start-up mentality
  • A good team player who can time-manage and work independently in a fast-paced and challenging environment
  • Strong organizational and analytical skillsFluency in English is mandatory

More jobs from AVVie GmbH:

If you require alternative methods of application or screening, you must approach AVVie GmbH directly to request this, as we're not responsible for the employer's application process.

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