sr manager quality systems & medical device reporting at biotronik@ BIOTRONIK
Portland, Oregon Metropolitan Area
Alex Myrwold
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San Diego State University
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FlashIntel GPTAlex Myrwold is a highly experienced professional with 16.3 years of work experience in the medical device industry. He possesses a wide range of skills including accounts receivable, editing, Microsoft Word, administrative assistants, and photography. Based in Vancouver, Washington, Alex is responsible for ensuring the quality management system adheres to FDA's Quality System Regulations 21 CFR 820 and ISO 13485 standards. He also holds certifications in ASQ Quality Auditor and Quality Process Analyst. Alex is skilled in problem-solving, lean management, Six Sigma, and DMAIC tools. He is known for his ability to solve problems and make processes leaner, faster, smarter, compliant, and more efficient.
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About
In the medical device industry, I'm responsible for ensuring the quality management system adheres to FDA's Quality System Regulations 21 CFR 820 and ISO 13485 standards. Along with ASQ Quality Auditor and Quality Process Analyst certifications, I have a deep understanding of CAPA, auditing, document control, device tracking, complaint/MDR handling, corrections/removals, and supplier quality subsystems. Throw in HIPAA and data privacy in there as well. I solve problems and make processes leaner, faster, smarter, compliant, and more efficient using Lean Management, Six Sigma, and DMAIC tools. Most importantly, I know how to tell a story.
...See MoreWork Experience
sr manager quality systems & medical device reporting at biotronik
Manager Quality Systems
Senior Quality Systems Specialist
Quality Systems Specialist
Medical Equipment Manufacturing
Alex Myrwold's Professional Milestones
- Quality Analyst Ii (2016-08-01~2017-08-01): Streamlining product quality processes and increasing product reliability through data analysis.
- Photographer (2008-08-01~2008-12-01): Captured memorable moments and breathtaking footage for various projects, exceeding viewer expectations and enhancing brand reputation.
Education
Journalism,
Bachelors,
Bachelor Of Arts
2007-2010Skill
Accounts Receivable
Editing
Microsoft Word
Administrative Assistants
Photography
Media Relations
Journalism
Proofreading
Creative Writing
Quality Assurance
Copy Editing
Writing
Documentation
Time Management
Capa
Change Control
Sop
Fda
Medical Devices
Technical Writing
Microsoft Excel
Outlook
Office Management
Invoicing
Microsoft Office 2007
Document Review
Webex
Microsoft Office
Powerpoint
Photoshop
Process Improvement
Cross Functional Team Leadership
Data Analysis
Minitab
Batch Release
Statistical Inference
Data Mining
Project Management
Six Sigma
Metrics
Spc
Data Visualization
U.s. Food And Drug Administration
Corrective And Preventive Action
Quality Auditing
Iso 13485
Quality System
Manufacturing
Gmp
Certification
Colleagues
Stephan Schulz-Gohritz
Chief Financial Officer | Investor | Competitive Athlete
Günter Behrens
Director Of Data Privacy In Service Operations
Luis Alves
Product Owner | Medical Devices | User Needs
Dr. Alexander Uhl
Chief Executive Officer
Max Fischer
Head Of Chief Financial Officer | Corporate Projects
Other Named Alex Myrwold
Frequently asked questions
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Alex Myrwold works for BIOTRONIK
Alex Myrwold's role in BIOTRONIK is sr manager quality systems & medical device reporting at biotronik
Alex Myrwold works in the industry of Medical Equipment Manufacturing
Alex Myrwold's colleagues are Stephan Schulz-Gohritz,Günter Behrens,Luis Alves
Alex Myrwold's latest job experience is sr manager quality systems & medical device reporting at biotronik at BIOTRONIK
Alex Myrwold's latest education in San Diego State University
