Karen Peifer
CQA, CMST, CSTE, CQIA * Risk-Based Software Quality & Validation Leader | Mentor
- Role
- Senior Requirements Engineer at Inspire Medical Systems
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Karen Peifer
I am a passionate and enthusiastic software quality and validation professional with over 27 years of experience in ensuring compliance and software quality for enterprise business systems. I am recognized for implementing and leading risk-based software validation programs that foster a seamless and efficient approach to execution, while developing high-quality validation packages. I have 13 years of experience working in regulated environments, where I have developed, implemented, and led testing for non-product software programs and solutions. Additionally, I provide guidance on regulatory compliance, create training materials, and mentor peers on efficient validation processes.
Experience
Senior Requirements Engineer
Aug 2025 — Present · St Louis Park, MN, US
Lead software quality process improvement activities.• Partner with and lead software change discussions with business owners to draw out gaps and understand proposed changes.• Take customers’ input/issues and transform these into customer needs and subsequently user and functional requirements.• Use validation subject matter expertise to draft non-product software validation procedures and software validation project documentation.• Perform software process and functional risk assessments.• Lead and coach on ISO and FDA compliance.
Skills
- Quality Assurance
- Business Analysis
- Visio
- Quality Center
- Research
- Waterfall
- Software Documentation
- Sdlc
- Testing
- Sharepoint
- Customer Collaboration
- Business Requirements
- Requirements Gathering
- Business Process Improvement
- Hp Quality Center
- Test Planning
- Software Quality Assurance
- Software Project Management
- Crm
- Cross-Functional Team Leadership
- Software Testing and Scripting
- Agile Methodologies
- Requirements Analysis
- User Acceptance Testing
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