Quality Engineer for Design Projects

Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 50 markets around the world.

Position: Quality Engineer for Design Projects (m/f)

Location: Jena, Germany

Reports to: Global Head of RA/QA

Primary responsibilities include support and guidance ofhte R&D depratmetn during the development and design transfer process. This will include working together closely with all departments involved in teh introduction of newly designed products into the market.

Your work will focus on

  • Support by the management of changes and the transfer from design to serial production, including coopera-tion in the management of tool for data analysis, collection of performance indicators and statistical process control etc.
  • Support involved technical departments in all Quality Assurance questions and ensure regulatory compliance with special focus on Design and Development Projects
  • Ensuring a compliant development process for site-based and multi-site development projects
  • Ensuring a ISO14971 compliant Risk Management System in Design activities
  • Development and Maintenance of Quality Engineering methods
  • Cooperation in the organization and conduct of internal and external audits, including supplier audits.

We are looking for a candidate, who

  • Successfully completed degree in a scientific or technical discipline (Bachelor level)
  • Minimum 5 year experience in the Medical Device Industry or similar regulated industry, ideally with wide-range technical experience in the development of Medical Devices
  • Base knowledge and experience in the function of a ISO14971 conform Risk Management Process
  • Ideally experience or training in various Quality Management tools (Lean, Six Sigma, etc)
  • Detail knowledge of design and development processes including Design Transfer to production and under-standing of the requirements for the manufacture of Medical Devices
  • Strong communication skills in English and German

If you are

  • a team player who likes challenges
  • a confident user of standard office software and familiar with Quality System Stadards (such as ISO13485 and FDA QSRs)
  • fluent in written and spoken German and English
  • excellent in leadership, communication, organization and time management
  • open to occasional international travel

Then we can offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products.

Are you interested?

Please send your application (cover letter, CV, references - all documents together in one pdf file), your salary expection and the earliest possible date for start of work to:

Occlutech GmbH
Ms Katrin Biedermann
Winzerlaer Str. 2
D-07745 Jena
katrin.biedermann@occlutech.com
Tel: 03641-508323
www.occlutech.com