Senior Quality Engineer(m/w/x)

In this role, you will actively shape product quality by defining metrics, leading initiatives, and guiding engineers on best practices. Your day-to-day responsibilities will involve analyzing failures, supporting manufacturing processes, and ensuring compliance with quality standards.

Anforderungen

• •Bachelor’s degree in electrical, mechanical or system engineering, math, or physics
• •Advanced degree preferred
• •5+ years of working experience in Quality Engineering or Process Engineering
• •Minimum 3 years in medical device design or manufacturing environment
• •Ability to navigate quality and compliance system with minimal oversight
• •Understanding of CFR 21 820/ ISO 13485 requirements
• •Experience in generating FMEA and process FMEA
• •Understanding of Design Controls and Change Controls
• •Proficiency in generating and executing Qualification and Validation protocols
• •Experience in leading product containment and rework activities
• •Proficiency in SPC & Six Sigma methodology and tools
• •Experience in typical Excel data analysis operations
• •Ability to create multi-source reports and interpret data with minimal oversight
• •Ability to think independently and make decisions based on limited information
• •Ability to initiate improvement discussions and lead teams
• •Ability to present information in various forms and forums
• •Excellent creative problem-solving skills
• •Excellent communication and documentation skills in English and German