Quality Systems Manager (m/f/d)

Date: Nov 19, 2022

Location: Dresden, SN, DE, 01277

Company: Heraeus

[title]
Quality Systems Manager (m/f/d)
Location Dresden
Permanent 
Full Time
 

 

About Heraeus

Solutions from Heraeus provide faster internet, rid water of germs, and keep hearts beating in time. As a leading international family-owned technology group, we combine materials expertise and technological leadership to create the most diverse products, all with one thing in common: World-class quality. Working with customers around the world, we shape the future and provide vital innovations in the areas of environment, electronics, health, and industrial applications. Heraeus is one of the top 10 family-owned companies in Germany and has a team of around 16,200 employees in 40 countries.

 

Main Tasks:

  • In your role you will be the contact person for the implementation of the local QM system and ensure that it is in line with the global QM system of Heraeus Medical Components. In doing so, you will identify improvement actions and be responsible for their introduction/implementation and work closely with Pilot Production, Development, Customer Support, Regulatory Affairs and the Quality area of the Heraeus Medical Components sites. You will establish and moderate a cross-functional quality circle.
  • When audits are performed by Notified Bodies, customers and authorities, you are the contact person and also responsible for our internal audit program, in which you plan and document the audits, but also audit internally yourself.
  • The process on corrective and preventive actions (CAPA) is your responsibility, you coordinate and monitor this process, but also the relevant standards and regulations and evaluate necessary changes.
  • You like to pass on your knowledge to the team in training sessions and document this in our software. You also monitor compliance with training schedules.
  • You are also interested in key figures, site-specific and global trend analyses and analyses for management reviews and you prepare these in reports for the responsible persons.

 

Job Requirements:

  • You have successfully completed your studies and have several years of experience in quality management/quality assurance in controlled industries such as medical technology, pharmaceutical industry, automotive industry, aerospace (ideally 5+ years).
  • Throughout your professional career you were able to acquire comprehensive knowledge of recognized QM systems (e.g. ISO13485/ FDA/ ISO14971) and apply them confidently.
  • Ideally, you have basic knowledge of regulatory requirements for medical devices (e.g. MDR, MDSAP) and are a proficient user of quality tools.
  • Daily communication and documentation in English is no challenge for you.
  • Your working style is independent, goal/solution oriented and structured, you are a team player and enjoy communication in diverse team structures.
  • Continuous learning is a matter of course for you and you enjoy technical trainings and further education.