Design Quality Engineer (m/f)

Description

• As an interface between quality, development and process design you accompany the development of medical implants and instruments by ensuring the accurateness of the applicable quality-related structures and regulations
• In close cooperation with the process owners for design control, who are located across sites, you ensure that all processes meet the international requirements and all necessary approval methods along with all documentation standards are established
• You analyze and supervise the compliance of procedures by verifying development records, design transfer protocols, validation reports and risk analyses and initiate corrective actions as necessary
• The introduction and monitoring of quality key data across sites regarding design control and risk management are part of your area of responsibility as well as independent creation and processing of reports and evaluations in order to encourage and support continuous improvement activities

• You are an engineer in the field of mechanical engineering, medical technology or have a degree in an equivalent subject of study
• You know the medical device norm ISO 13485 very well and have profound experience in quality management, ideally in the medical device industry
• Moreover, you are familiar with QSR and have knowledge of measurement technology and manufacturing engineering
• Very good English skills
• Good experience in project management and with the typical MS Office applications
• Team player, strong communication skills and independent work style