Quality Assurance Manager (m/f/d)

Tec4med develops the next generation of tech, cloud and IoT solutions for the (pharma) logistics industry and helps to transport sensitive goods like medicines, organs, or vaccines safely around the world. For the expansion of our team in Darmstadt we are looking for a pro-active and motivated Quality Assurance Manager.

Your responsibilities:

  • Maintenance of our certified quality management system according to ISO 9001
  • Help with the QA software integration and merge into the QA-Software VEEVA
  • Maintenance and support of our initial audit for our certified calibration lab according to ISO 17025
  • Setup, maintenance and implementation of QA-related topics in the development of new hardware and software such as country-, safety-, EMC-, and airline certifications and approvals
  • Maintenance and support of software validation according to GAMP 5 guideline
  • Support of external client audits and preparation and execution of internal audits
  • Preparation of management reports with monitoring and enforcement of required corrective and preventive actions

What we expect:

  • Profound knowledge of the ISO 9001 standard
  • Know-how in the areas of ISO 27001, 21 CFR Part 820 /11, ISO 13485 or GAMP 5 are a plus
  • You're really into pharma, cloud, IoT and tech and you can inspire yourself for it
  • You are fluent in written and spoken German and English
  • You are open-minded, curious and persevering
  • You have a feel for and/or understanding of digital markets/business models
  • You have the motivation to get deeply involved in topics and become an expert in them
  • min. 2-3 years of professional experience in a Quality-Management related position

That awaits you:

  • Flat hierarchies, short decision-making processes, open corporate culture
  • Opportunity to work with an innovative international team
  • Flexible working hours
  • Hybrid working
  • Working on solutions that save lives and improve global health
  • Attractive remuneration package: A competitive salary, including additional benefits such as training, share package and team events