Arnt Danielsen
Quality Systems Management | Regulatory Compliance | Audit Programs Development & Execution | Team Building, Training, & Leadership | CAPA Implementation & Management | Critical Thinking | Problem-Solving
- Role
- Quality Systems Supervisor at Medtronic
- Location
- Ann Arbor, MI, US
- LinkedIn followers
- 500 followers
About Arnt Danielsen
Passionate about quality and precision, I bring over a decade of leadership experience in quality assurance, audit management, and regulatory compliance within the medical device industry. My career is built on a commitment to maintaining the highest standards, ensuring that every product and process aligns with global regulations like ISO 13485:2016, FDA CFR Part 820, and EU MDR 2017/745.Throughout my journey, I\'ve had the privilege of designing and executing robust quality programs that not only meet but exceed regulatory requirements. Whether leading cross-functional teams, developing impactful training programs, or executing internal and external audits, I’ve consistently driven operational efficiency and enhanced compliance. My strategic approach to project management has resulted in successful, zero-finding audits, and my ability to align quality objectives with organizational goals has earned recognition from both peers and leadership.Key areas of expertise include:Quality Systems Management | Regulatory Compliance | Audit Programs Development & Execution | Continuous Process Improvement | Team Building, Training, & Leadership | Audit Schedule Development | CAPA Implementation & Management | Root Cause Analysis | Scribe Development Programs | Creativity | Critical Thinking | Problem-SolvingTechnologies:Microsoft Office Suite (Excel, Word. PowerPoint)| BAMCS | MAPPER | Microsoft Dynamics Great Plains | JDE for MRP/ERP systems | EtQ Reliance Quality Management Software | SAPLet’s connect if you’re interested in discussing how quality and compliance can drive success in the medical device industry!
Experience
Quality Systems Supervisor
Oct 2024 — Present
Education
Lillestrom - Norway
Associate's
New Mexico State University
Bachelor of Business & Administration
Skills
- Purchasing
- Failure Mode and Effects Analysis (Fmea)
- Process Improvement
- U.s. Food and Drug Administration (Fda)
- Manufacturing
- Quality Assurance
- Design Control
- Supply Chain Management
- Strategic Sourcing
- Medical Devices
- Capa
- Validation
- Sourcing
- Cross-Functional Team Leadership
- Dmaic
- Continuous Improvement
- Supply Management
- Fmea
- Iso 13485
- Business Process Improvement
- Fda
- Quality System
- Product Development
- Lean Manufacturing
- Root Cause Analysis
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