(Senior) Quality Engineer Medizintechnik(m/w/x)

Beschreibung

In this role, you will play a vital part in ensuring the quality of innovative medical devices. Daily tasks will involve leading quality operations, driving improvements, and collaborating with various teams to maintain high standards and compliance.

Anforderungen

• •Bachelor’s degree in Medical Engineering, Electrical Engineering, Mechanical Engineering, Industrial Engineering, or comparable scientific field
• •At least 2 years of experience in Quality Engineering, preferably in the medical device industry
• •Solid understanding of quality systems, root cause analysis, and manufacturing support
• •Strong communication skills and ability to work effectively in cross-functional teams
• •Structured, solution-oriented, and proactive working style
• •Fluency in German and English
• •Familiarity with ISO 13485, FDA regulations, and NC/CAPA processes
• •Experience in complaint handling and post-market quality activities
• •Hands-on experience with TrackWise, PLM systems, or validation management tools
• •Knowledge of supplier quality management and external quality collaboration

Aufgaben

• •Support daily quality operations in serial manufacturing
• •Lead root cause analyses for quality issues
• •Implement corrective and preventive actions (CAPA)
• •Manage quality records using TrackWise and ValGenesis
• •Act as a key interface between Quality, Manufacturing, and Engineering
• •Drive quality improvement initiatives
• •Support cost-reduction activities
• •Coordinate with suppliers on quality topics
• •Assist in supplier issue resolution
• •Contribute to regulatory compliance in manufacturing processes
• •Support audit readiness and participate in audits and inspections

Tools & Technologien