Quality System Specialist (m/f/d)

Date: Nov 17, 2022

Location: Dresden, SN, DE, 01277

Company: Heraeus

[title]
Quality System Specialist (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 as Quality System Specialist you will support the Quality Manager and the site in the implementation of corrective and preventive actions and document control. As part of the team, this will allow you to continuously support the optimization of quality processes and products and work closely with other functions like Pilot Production, Development, Customer Support and Regulatory Affairs.
  • You will be happy to pass on your knowledge to the team in training sessions and document this in our software. As an expert in training issues, you will support other trainers and be the point of contact for system issues.
  • Identifying corrective and preventive actions (CAPA) is your responsibility, you coordinate and moderate them and monitor their realization and effective implementation. You will gladly take over the implementation in our software platform.
  • In your function you plan internal and supplier audits, process them and create the documentation; you administrate and archive audit reports reliably for our site.
  • You will administer and support the areas of customer complaints/complaints as well as supplier monitoring and requalification, thus ensuring the implementation of our quality system.
  • You have a passion for numbers, key figures and for trend analyses and can provide these for management reviews.

 

 

Job Requirements:

  • You have successfully completed vocational training or a successfully completed a degree (Bachelor).
  • Ideally, you have experience in quality, CAPA management/quality assurance in controlled industries such as medical technology, pharmaceutical industry, automotive industry, aerospace (ideally at least 3 years) and enjoy specialized training and further education.
  • Basic knowledge of the relevant standards (e.g. ISO 13485/ 21CFR820 / ISO 14971) complete your profile.
  • You have a good command of written and spoken English, are solution-oriented, a team player and enjoy working in an international environment where you can demonstrate your excellent communication skills.
  • A qualification as an internal auditor as well as knowledge of root cause analysis / problem solving methods (e.g. 5Why, Ishikawa) are desirable.