Beschreibung

In this role, you will drive process excellence by designing and improving business processes for product verification and manufacturability. By collaborating with cross-functional teams, you will ensure compliance and enhance product quality throughout the development lifecycle.

Anforderungen

• •5+ years of relevant experience in process management within the medical device or pharmaceutical industry
• •Strong knowledge of product development, verification processes, design controls, and DFM principles
• •Excellent strategic thinking, problem-solving, and analytical capabilities
• •Ability to influence and communicate effectively across all organizational levels
• •Ability to work in a fast-paced, global environment with multiple priorities
• •Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field
• •Fluency in English
• •Familiarity with PLM systems and digital documentation workflows
• •Experience applying agile methodologies in process design
• •Certification in Lean Six Sigma, Process Management or Project Management is a plus
• •Training in DFM methodologies and verification standards preferred
• •Experience with ISO 13485, FDA regulations, or similar compliance frameworks
• •German skills are a plus

Aufgaben

• •Design and implement end-to-end business processes for Design Verification and DFM
• •Continuously improve processes related to Design, Risk Management, Testing, and Manufacturing Readiness
• •Ensure compliance with regulatory and quality standards throughout the product lifecycle
• •Collaborate with R&D, Quality, Regulatory, Manufacturing Engineering, Operations, and IT to harmonize processes
• •Develop and maintain process documentation, including Work Instructions, Templates, and Guidelines
• •Create training materials to ensure compliance with medical standards and company QMS
• •Conduct workshops and training sessions to identify process gaps and support change management
• •Translate business needs into functional solutions with system architects for PLM implementation
• •Monitor process performance and report KPIs to drive continuous improvement
• •Collect user feedback to enhance process efficiency

Tools & Technologien

Benefits