For our client, a leading Biotech company who develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing, we are currently looking for this permanent position in Munich:

Senior Design Quality Engineer (m/w/d)

Vertragsart: Festanstellung

Auftragsnummer: A505-796

Startdatum: 01.01.2019

Einsatzort: München

Job-Beschreibung:


Ihre Aufgaben:

  • Reporting to the Design Quality Manager, the Quality Engineer support new product development (laboratory automation and related softwares) from a QA perspective
  • He/she provides guidance to the core team to organize project structure and documentation to meet design control requirements
  • Support design changes to established products
  • Ensure conformity of the design process with applicable regulation
  • Represent QA function within the core teams in charge of the development process
  • Responsible for DHF completeness and maintenance
  • Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics
  • Generate and maintain the risk management files
  • Develop and execute validation protocol
  • Review and Approve design and development documentation related to the products he/she’s in charge

Ihre Qualifikationen:

  • Degree in sciences, life sciences, engineering or quality management or Equivalent education gained through work experiences
  • 3 years+ experience within the regulated environment of in vitro diagnostics or medical devices
  • Fluent in English-written and verbal
  • Experience in design verification and validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment
  • Practical experience with product software verification and validation – development experience is a plus
  • Knowledge of EN62304, ISO14971, EN62366, EN61010
  • High level of autonomy and critical thinking is required
  • Teamwork oriented
  • Computer skills (MS Office products)
  • Clean driving record – ability to travel as required