Description

In this role, you will lead the Quality team at the Seefeld facility, ensuring compliance with quality regulations while driving continuous improvement in product and process quality. Your daily responsibilities will include guiding teams, resolving issues, and implementing effective quality strategies.

Requirements

• •Bachelor’s degree or higher
• •Fundamental Medical Device, Pharmaceutical, or Combination Product experience in a Quality function
• •Quality management experience demonstrating team leadership
• •ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational Excellence, or Certified Six Sigma Black Belt
• •Skills in Competent Authority Interaction and Influence, External Audit Readiness & Management, Medical Device, Nonconforming Material Control, Customer Interaction and Support, Quality Engineering, Process Validation, Process Control & Monitoring, Risk Reduction, Continuous Process and Product Improvement, Field Actions & Recalls, and Organizational Leadership
• •Demonstrated successful organizational influence in compliance excellence, continuous improvement, product-related risk mitigation, and process capability and efficiency enhancement
• •Strong verbal and written communication skills
• •Strong leadership, decision-making, problem-solving, continuous improvement, and management skills

Tasks

• •Serve as the Quality Management Representative for the manufacturing site
• •Lead the site Quality team and provide expert-level guidance
• •Supervise quality engineering professionals and set performance objectives
• •Interpret product and performance data to respond to customer needs
• •Resolve nonconformances and support business objectives
• •Drive continuous improvement by defining guidelines and priorities
• •Initiate and approve improvement projects for product and process capabilities
• •Identify and lead compliance improvement opportunities for quality regulations
• •Guide internal teams in developing quality strategies for medical devices
• •Maintain effective Quality metric performance and resolve performance issues
• •Provide peer leadership to enhance compliance and risk management
• •Utilize industry technologies for process control and trend analysis