Quality Manager (m/w) Medical Devices

Position: Quality Manager (m/w) Medical Devices
Hiring Manager(s): QMB
Company: Precisis AG
Location: Heidelberg/Munich Germany

Company Overview:
Precisis is a well-funded startup that is developing neuromodulation technologies that are focused (initially) on epilepsy and have two distinct advantages over current technologies in the market. Less invasive and targeted therapies for patients are the foundation of Precisis’ projects. Our team of 10 is made up of experienced and entrepreneurial-minded individuals that have a common goal of bringing to market next generation neuromodulation solutions.

Position Description:
  • Maintenance and improvement of the established quality management system according to the related requirements of ISO 13485, MPG and AIMD 90/385/EEC
  • Member of the Risk Management Team
  • Administration of QM related documents and records
  • Analysis and improvement of processes
  • Preparation and performance of quality related employee trainings
  • Preparation, attendance or performance of internal, external and supplier audits

Preferred Experience:
  • Academic degree with scientific or technical focus or equivalent qualification
  • 2 or more years of experience within the medical device industry (preferably AIMD or MDD Software)
  • Collaboration in risk management and product registration processes
  • Good knowledge of standards and regulatory requirements (ISO 13485, ISO 14971, MPG)
  • Process oriented Solution focused personality
  • Good written and oral communication skills in English and German

Benefits:
  • International and innovative work environment
  • Collaboration in a dynamic and innovative team
  • Open door policy
  • Various opportunities for individual training and development

Precisis AG (www.precisis.com) is associated with exceptional achievements with medical devices in the field of brain therapy. Our latest development, the fully implantable EASEE neurostimulation system, will provide an modern and low-risk method for the suppression of epileptic seizures in drug resistant patients. EASEE is a minimally invasive brain stimulation