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
Projektdauer: 10 MM
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