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Job Information

QA Engineer Compliance

Information About this Role


QA Engineer Compliance, Hechingen, Germany (m / w)

They support the upcoming compliance projects (eg MDR, FDA, MDSAP) They monitor applicable laws and standards and ensure regulatory compliance They conduct internal audits and support the preparation of external audits

  • They carry out process optimisations as well as TQM measures and optimize the QMS
  • Support the implementation of supplier audits
  • Carry out various QMS trainings
  • Prepare internal key figures for the management review
  • Undertake various projects, actively support corrective measures and present solutions
  • Work in a team but are involved in the implementation of the projects "hand-on"
  • Support tasks in international approvals of our vascular products (stents and stent grafts)
  • For international approvals, answer questions that arise with the creation of technical files
  • Support departments in all QA / RA-related issues

Requirements:

  • Science or engineering degree
  • Several years of professional experience in the field of quality management and compliance, ideally medical technology in the vascular area
  • Very good knowledge of ISO 13485: 2016
  • Knowledge of the new MDR, 21 CFR Part 820, MDSAP are beneficial
  • Knowledge of ISO 14971 risk management and / or compliance handling is an advantage
  • Understanding of international regulatory requirements for QMS
  • Very good German and English knowledge in spoken and written Good knowledge of MS Office and ERP systems Independent, structured and responsible working method as well as teamwork and resilience