Process Engineer(m/w/x)

Requirements

• Degree in Mechanical, Manufacturing, Industrial Engineering, or related
• Experience in manufacturing, process, or quality engineering
• Strong knowledge of NC/CAPA processes
• Familiarity with regulatory and quality standards
• Excellent problem-solving, analytical, and documentation skills
• Proficiency in process improvement tools
• Strong communication and teamwork skills
• Proven experience in project leadership
• Fluency in English and ideally German
• Attention to detail and organizational skills
• Ability to manage multiple priorities
• Continuous improvement mindset and proactive approach
• Commitment to quality and compliance

Tasks

• Support and improve manufacturing processes
• Ensure product quality and operational efficiency
• Lead investigations for non-conformances, CAPAs, and audit observations
• Document product bounding and disposition
• Perform root cause analysis for quality issues
• Define corrective and preventive actions
• Lead cross-functional investigation teams
• Ensure timely implementation of corrections and CAPAs
• Prepare and maintain documentation for process improvements
• Serve as subject matter expert for audit deviations
• Analyze processes to optimize quality, cost, and throughput
• Revise work instructions and standard operating procedures
• Maintain compliance with ISO, FDA, and GMP requirements
• Collaborate with Quality, R&D, Production, and Supply Chain teams
• Provide technical support and training to production personnel
• Contribute to manufacturing best practices and continuous improvement

Work Experience

Education

Languages

Tools & Technologies