Barbara Beiersdorf

About Barbara Beiersdorf

Quality Systems Leader with an in-depth understanding of FDA and international regulations and how to implement in Class 3 medical device, pharmaceutical, and IVD companies in a way that makes business sense. Spearheaded global development and implementation of multiple systems, including CAPA, product design and development, audit management, document control, supplier management, management reviews, and training, leveraging strong communication skills and the ability to communicate up and down the ladder. Strong leader focused on meeting objectives with a collaborative, supportive management style that has resulted in high-achieving, motivated team members.

Experience

1. Vice President of Quality

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   Oct 2025 — Present · Brooklyn Park, MN, US

   Management and oversight of the Quality Management System, Design Quality, and Manufacturing Quality. Leads, oversees, and defends the strategy, execution, and continuous improvement of all quality related activities for both investigational and commercialized product. Management Representative.

Education

• UMN Carlson School of Management

  Master of Business Administration (MBA), Information and Decision Sciences

• St. Cloud State University

  Master of Science (M.S.), Medical Technology Quality

  2012 — 2014

• St. Catherine University

  Bachelor's degree, Quantitative Methods and Computer Science

Skills

• Supplier Quality
• Iso 14971
• Root Cause Analysis
• Regulatory Affairs
• Design Control
• Program Management
• Gxp
• Quality Auditing
• R&D
• Validation
• Trackwise
• Quality Control
• Iso
• Enterprise Systems Implementation
• Fda
• Gmp
• Medical Devices
• Capa
• Fmea
• Regulatory Requirements
• Fda Gmp
• Risk Management
• Spc
• Design of Experiments
• Manufacturing
• Quality Assurance
• Pma
• Glp
• Gamp
• Quality System
• V&V
• Minitab
• Testing
• Change Control
• Coaching
• Medical Device Directive
• Cqa
• Quality Management
• Dmaic
• Management