The HARTMANN GROUP is one of the leading European providers of medical and hygiene products with core competences in wound treatment, incontinence care and infection protection. The portfolio is supplemented by products for compression therapy and first aid. Moreover, HARTMANN offers innovative system solutions for professional target groups in the medical and care sector. The company with its headquarters in Heidenheim/Germany, whose priority market is Europe, has operations around the world. In 2016, just over 10,300 employees in the HARTMANN GROUP generated sales of about EUR 1,986.5 million.

Your area of responsibility:

  • You will be responsible for the independent definition, planning of Audit Concepts and execution of audits and the enforcement of quality standards for the HARTMANN Group
  • This will also include the coordination of immediate actions, corrections, corrective actions and the coordination of audit CAPAs
  • The analysis of processes and quality problems, identification and documentation of risks, weaknesses as well as the development of proposals for continuous sustainable improvements will also be essentials of your task
  • A further focus will be the integration of internal system audits with process / product and supplier audits into one concept of quality management and quality assurance system
  • You will accompany external audits, such as customer and authority audits and you will manage, lead and support HARTMANN audit teams during those audits
  • As an enabler you will organize and lead trainings for the auditors
  • You will be the process owner of global audit processes
  • The future-oriented continuous development and documentation of relevant group-wide processes will be in your responsibility

What we look for:

  • Successfully completed university studies with a business, engineering or information technology background or comparable training
  • Certification and/or education as Quality Auditor in the Medical Device Business is a MUST
  • Very good knowledge of current regulatory & cGMP requirements (EU and FDA) and of the standards ISO 9001 & ISO 13485 & 21 CFR Part 820
  • Professional experience of at least 5 years in the medical device industry is expected
  • Experience with execution of system, process and product audits as well as supplier audits is beneficial
  • As a person you are having strong analytical and problem-solving skills
  • You are convincing with excellent communication skills with persuasive power and assertiveness on the one hand and by diplomacy and flexibility on the other
  • You are willing and able to work independently, team-oriented with a high degree of responsibility
  • You are willing to travel domestically and internationally
  • Your German and your English are both business fluent – oral and in writing

Your contact

Ms Friederike Stracke

PAUL HARTMANN AG, Human Resources Management

P.O. Box 1420, 89504 Heidenheim, Germany

If you wish to join our company, we will appreciate to receive your informative application with cover letter, curriculum vitae and copies of certificates.