Andrea Roether

About Andrea Roether

I have a diversified background in Medical and EMS Product Quality System processes as a manager and leader driving creative solutions through collaborative problem solving using Lean/Six Sigma methodologies. My specialization areas include manufacturing quality and quality system process optimization, CAPA and Audit Management, post market surveillance, re-engineering and management of quality system tools. What differentiates me from my peers is my energy, detail oriented, analytical and data driven approach, which provides a strong basis for quality system processes and computer system design, as well as validation and monitoring. I am also highly recognized for leading successful collaborative teams in projects, organizational integration, and remediation efforts. I have professional certifications in the following areas: Six Sigma Black BeltLean Boot CampQuality ProfessionalProject ManagementLead CAPA InvestigatorTrainer and Train the TrainerI have formal ASQ certifications in Auditing, Operational Leadership, PMP, and Lean/SS Green Belt.Key Characteristics- Collaborative- SIPOC oriented - value stream, system and lean process driven- Builds confidence and credibility in teams and individuals- Fun, energetic, and passionate

Experience

1. Senior Director of Global Quality

   Creation Technologies

   Apr 2024 — Present · US

   Responsible for the QMS and overall quality culture across Creation technologies at the global and regional level. Accountable for ensuring our 14 sites QMS is well executed and matures through collaborative continuous improvement with the support of our global quality shared services team. Responsible for FDA interactions, and quality related integration activities.

Education

• College of Lake County

  Associate of Science (A.S.), Biology, General

• College of Lake County

  Associate’s Degree, Clinical Laboratory Science/Medical Technology/Technologist

• Kennedy-Western University

  Bachelor of Science - BS, Management and leadership

• Kennedy-Western University

  Bachelor of Science (B.S.), Organizational Leadership

Skills

• Change Control
• Quality Auditing
• Verification and Validation (V&V)
• U.s. Food and Drug Administration (Fda)
• Medical Devices
• Cross-Functional Team Leadership
• Capa
• Quality System
• V&V
• Continuous Improvement
• Management Review
• Process Improvement
• Quality Control
• Gmp
• Regulatory Requirements
• Validation
• Iso 13485
• Product Trend
• Complaint Management
• Team Management
• Recall
• Collaborative Problem Solving
• Corrective and Preventive Action (Capa)
• Business Process Improvement
• Fda
• Quality Assurance
• Product Complaints