Open positions

Posted |

February 03 2020

Locations |

Slovenia

Quality Manager (Medical)

Are you up for a challenge? We are currently engaged in some very exciting and challenging projects in the Medical industry. If you have experience in quality assurance, and you are meticulous about meeting standards, then you might be just the right candidate for the job.

We are looking for an experienced Quality Manager to join our Medical software development team.

Some of the requirements are listed below:

  • Bachelor’s degree in Computer Science, Electrical Engineering or a combination of relevant education and experience
  • 7+ years of experience in QA-related functions
  • Working knowledge of ISO 13485, IEC 62304, ISO 14971 standards and EU Medical Device Regulation (EU 2017/745)
  • Ensuring processes needed for the Quality Management System (QMS) are established, implemented, and maintained
  • Hands-on involvement in the implementation of an ISO 13485 QMS and continuous improvement plans
  • Having ISO internal or lead auditor certifications is desirable
  • Following changes in applicable quality standards and Medical Device regulations
  • Providing guidance and participate where appropriate in Software development project reviews and activities from a quality and documentation perspective
  • Organizing internal audits, auditing all software development processes and engineering team to assure procedures are being followed
  • Experience with software development projects and understanding of medical device product development life-cycle
  • Reporting to management on the performance of the QMS and any needed improvements
  • Experience in interacting with Regulatory authorities and Auditing Bodies

Additional requirements:

  • Fluency in spoken and written English
  • Ability to quickly learn and apply new concepts, principles, and solutions
  • Self-motivated and resourceful with good interpersonal skills
  • Highly organized with excellent attention to detail
  • Excellent oral and written communication skills
  • Strong ability to communicate regulatory and quality requirements clearly and effectively and to interact with clients as needed

We offer you:

  • A chance to work with an outstanding team of people
  • Great environment for personal and professional development
  • Opportunities for additional professional training and certification, free language classes
  • Stable and well-organized working conditions with a multitude of different exciting projects to work on
  • A dynamic environment within a technologically advanced organization
  • Encouragement of innovation and questioning the status quo, sharing ideas and knowledge