Design Assurance Engineer / Medical Devices (m/f/d)

• Support on creation of overall superior quality plan including document plan and overall VnV plan
• Review of design verification and validation test specification for medical devices (equipment and consumables)
• Review of design control documents according to GLP, GDP, CFR820
• Member of the product and design FMEA team

• Contribute to the content of the risk management throughout the product development
• Review of the systematics and completeness of the risk analysis
• Evaluation of risk-reducing measures regarding impact on severity of damage and probability of occurrence
• Creation and review of the evidence for implementation and effectiveness of the measures

• Involvement in the preparation of test specifications and test requirements for the series testing of medical devices

• Active participation in measures for synchronization and improvement of processes
• Failure analysis for field returns and during development
• Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions by quality/environmental officers and the specialist for occupational safety

• Completed technical and/or physical studies
• At least 2 years of professional experience
• Experience with product quality in a highly regulated industry (medical device, automotive, aviation etc.)
• Experience in theory and application of quality methods and techniques
• English fluency, Germany would be plus
• Quality-conscious, trustworthy and reliable
• Team player
• Good communication skills
• Structured and systematic way of working
• Eligible to work legally in Germany

• Willingness to travel to all locations and business contacts (10%)

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