Jack McCutcheon Email & Phone Number
Director of Quality Assurance and Regulatory Affairs
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Jack McCutcheon Location
- Beaverton, OR, US
Jack McCutcheon Work
- Director of Quality Assurance and Regulatory Affairs @ Pulse Health LLC (July 2017 - Present)
- Senior Quality Assurance and Regulatory Affairs Engineermmanager @ Electrical Geodesics, Inc (December 2013 - June 2017)
- Audit Committee Chairman @ (September 2011 - November 2013)
- Bio-Pro Steering Committee Member @ (January 2009 - November 2013)
- Qaulity Assurance Regulatory Affairs Mgr. @ (June 2009 - November 2013)
- Operations Manager @ Parks Medical Electronics (June 2003 - September 2007)
- Manufacturing Manager @ Tektronix (January 1980 - January 1990)
Jack McCutcheon Education
- Oregon Institute of Technology
BS (Industrial Management)
1989-1994 - College of the Redwoods
A (Certificate in Electronics Technology, Certificate in Biomedical Electronics, and Electronic Comm.)
1977-1980
Jack McCutcheon Skills
- Certified Lead Auditor ISO 13485:2003
- Medical Devices
- Regulatory Affairs
- Lean Manufacturing
- 510(k) PreMarket Notifications
- Cross-functional Team Leadership
- ISO 13485
- FDA
- Customs /FDA requirements for "Import for Export" Medical Devices
- Own Brand Labeling CE mark requirements
- Microsoft Excel
- Lean Tools
- Lean Process Improvement
- Team Building
- Customer Service
- Good Clinical Practice (GCP)
- Organizational Development
- Quality Control
- Risk Management
- Risk Assessment
- Validation
- Quality System
- Corrective and Preventive Action (CAPA)
- Good Manufacturing Practice (GMP)
- Quality Assurance
- Quality Management
- Design Control
- Quality Auditing
- Manufacturing
- 21 CFR
- Clinical Trials
- Process Control
- Supplier Quality
- Standard Operating Procedure (SOP)
- Regulatory Requirements
- Quality Engineering
- Regulatory Submissions
- Manufacturing Operations
- Change Control
- ISO 14971
- Computer System Validation
- Regulatory Compliance
- Regulatory Reporting
- Global Regulatory Compliance
- Regulatory Audits
- Manufacturing Operations Management
- Business Development
- Continuous Improvement
- GMP
- Management
- 510k Premarket Notifications
- Cross Functional Team Leadership
- Certified Lead Auditor Iso 13485
- Fda Requirements for "Import for Export" Medical Devices
- Customs
- 510 Premarket Notifications
- Good Clinical Practice
- Corrective and Preventive Action
- Good Manufacturing Practice
- Standard Operating Procedure
Jack McCutcheon Summary
- Jack McCutcheon, based in Beaverton, OR, US, is currently a Director of Quality Assurance and Regulatory Affairs at Pulse Health LLC. Jack McCutcheon brings experience from previous roles at Electrical Geodesics, Inc, Oregon Bioscience Association and SAM Medical Products. Jack McCutcheon holds a 1989 - 1994 BS in Industrial Management @ Oregon Institute of Technology. With a robust skill set that includes Certified Lead Auditor ISO 13485:2003, Medical Devices, Regulatory Affairs, Lean Manufacturing, 510(k) PreMarket Notifications and more. Jack McCutcheon has 2 emails and 4 mobile phone numbers on RocketReach.
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