Quality Engineer MedTec

vor 2 Monaten

Vienna, Österreich AVVie GmbH Vollzeit

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

If you are interested in joining a young and international start-up active in medical technology in Vienna.

Tasks

Primary responsibility is to ensure quality and regulatory compliance during the design and development of transcatheter mitral valve devices in our Vienna prototyping lab.

  • Take ownership, implement and maintain the quality management system (ISO 13485 & US FDA QSR) in cooperation with external consultant
  • Support the R&D team with all quality related issues.
  • 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 employee trainings on QMS documents
  • Determining training needs, acting as a catalyst for change and improvement in performance and quality
  • Assists in coordination and management of all internal, supplier and external audits.
  • Perform routine audits (internal & external) and quality tests.
  • Provide support in identifying deficiencies in quality systems, defining and implementing systematic improvements
  • Drive project activities to ensure timely completion of quality-related project milestones
  • Lead the periodic quality review meetings
  • Identifies risks and performs trending of complaints, deviations, and audit findings, and identifies appropriate corrective and preventative measures
  • Other duties assigned by direct supervisor
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 Ill medical devices)
  • Deep practical knowledge of ISO 13485 and ISO 14971 requirements and other ISO standards relevant to AVVie’s development
  • Experience in compliance activities, including but not limited to notified body audits, FDA inspections, and other regulatory agency inspections and audits.
  • Ownership of relevant processes, policies and projects
  • Where applicable and previously defined, act of behalf of the company in communication with competent authorities and notified bodies
  • Be a contact point for other departments for quality-/IMS-related topics
  • Performance evaluation for direct reports

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