Beschreibung

As a Design Assurance Engineer, you will focus on ensuring the quality of medical devices by creating quality plans, reviewing specifications, and participating in risk management. This role involves collaborating with teams to enhance processes and maintain compliance with regulations.

Anforderungen

• •Completed technical and/or physical studies
• •At least 2 years of professional experience
• •Experience with product quality in a highly regulated industry
• •Experience in theory and application of quality methods and techniques
• •English fluency
• •German language skills would be a plus
• •Quality-consciousness
• •Trustworthiness
• •Reliability
• •Team player
• •Good communication skills
• •Structured and systematic way of working

Aufgaben

• •Create an overall quality plan
• •Review design verification and validation specifications
• •Review test specifications and reports for medical devices
• •Review Design Control documents according to GDP and MDR 2017/CFR820
• •Lead and contribute to risk management activities
• •Participate in FMEA and other quality assurance tasks
• •Support the creation of a document plan and overall VnV plan
• •Contribute to risk management content throughout product development
• •Review the completeness of risk analysis
• •Evaluate risk-reducing measures for severity and probability
• •Create and review evidence for implementation of measures
• •Prepare test specifications and requirements for series testing
• •Participate in process synchronization and improvement measures
• •Conduct failure analysis for field returns and during development
• •Ensure compliance with quality, safety, and environmental regulations