James Ledlum Email & Phone Number
Vice President of Quality and Regulatory Operations @ Covetrus
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James Ledlum Location
- Minneapolis, MN, US
James Ledlum Work
- 2025 -now Vice President of Quality and Regulatory Operations @
- 2023 -now Executive Operations Quality and Regulatory Consultant @ JammieOne LLC - Quality and Regulatory Solutions
- 2023 -2024 Sr. Director, Operations @
- 2021 -2023 Sr. Director, Global LS Quality and Regulatory - Entegris Global Life Science @
- 2020 -2021 Director Global Quality Engineering, Global Operations @
- 2017 -2020 Director, Quality Engineering (Corporate, Breast and Skeletal Health and Gyn Surgical Solutions) @
- 2015 -2017 Director, Corporate Supplier Quality Engineering @
- 2015 -2015 Supplier Quality Engineering Manager (Zimmer Spine) @
- 2013 -2015 Corporate Supplier Quality Leader @
- 2013 -2015 Supplier Quality Engineering and Purchasing Controls Workstream Guide and Guru (Zimmer Corporate) @
- 2012 -2013 Interim Supplier Quality Leader (Asia Pacific) @
- 2011 -2013 Senior Supplier Quality Engineer and Supplier Quality Audit Champion @
- 2009 -2011 Senior Corproate Quality System Engineer @
- 2007 -2009 Quality System Engineer (Guidant CRM - A Boston Scientific Company) @
- 2004 -2007 Process Quality Control Engineering @
- 1999 -2004 Reliability and Mechanical Engineering Technician (Reliability and Failure Analysis Lab) @
- 1998 -1999 Manufacturing Operator @
James Ledlum Education
- UW-Stout Polytechnic
Masters (Technology Management (Specialty: Production Ops - Includes Quality Management & Strategic Planning))
- University of Wisconsin-Stout
Bachelors (Industrial Management (Specialty: Industrial Engineering: Minor: Quality Engineering Management))
- NEI College of Technology
Associates (Electronics Technology)
- Haywood Mission Academy
High School Diploma
- B. W. Harris
Elementary School (Elementary School)
James Ledlum Skills
- FDA
- ISO
- Supplier Quality
- Quality Auditing
- GMP
- Supplier Development
- Project Management
- GLP
- Quality System
- ISO 13485
- Six Sigma
- CAPA
- Medical Devices
- Design Control
- DMAIC
- V&V
- SPC
- Quality Control
- Manufacturing
- Cross-functional Team Leadership
- Testing
- Process Improvement
- FMEA
- Root Cause Analysis
- Validation
- Minitab
- Quality Management
- Design of Experiments
- Quality Assurance
- 21 CFR Part 11
- Engineering
- Change Control
- Lean Manufacturing
- Auditing
- ISO 14971
- Supply Chain Management
- Continuous Improvement
- Iso 9000
- Value Stream Mapping
- Manufacturing Engineering
- 21 CFR
- U.S. Food and Drug Administration (FDA)
- ISO Standards
- Corrective and Preventive Action (CAPA)
- Statistical Process Control (SPC)
- Verification and Validation (V&V)
- Failure Mode and Effects Analysis (FMEA)
- Business Process Improvement
- Fda Gmp
- Writing
- Suppliers
- Supplier Audits
- Corrective Actions
- Workstream
- 5s
- Clinical Research
- Lcc
- Cans
- Mentoring
- SAN
- Dispositions
- Cross Functional Team Leadership
- Non Conforming
- u.s. Food and Drug Administration Fda
- Assessment
- Closure
- Regulatory Agencies
- Management
- Msn
- Coaching
- Science
- Industrial Organization
- CRM
- APAC
- System Requirements
- Monitors
- Boston
- Execution
- Qualification
- Supplier Evaluation
- Guidance
- Statistical Process Control Spc
- Capas
- System
- BSC
- Asia
- Agreement
- Complexity
- Strategies
- Ecos
- Medicine
- Training
- Characteristics
- Failure Mode and Effects Analysis Fmea
- Root Cause
- Robust
- Engineering Change
- Streamline
- Product Development
- Trains and Add Rails
- System Monitoring
- Partnerships
- Analysis
- Indiana
- Cardiac Rhythm Management
- Supplier Rationalization
- ROOT
- Trident
- R
- Commodities
- Harmonization
- Production Operations
- Cross Functional Team
- Verification and Validation V&V
- FIX Protocol
- Pacemakers
- Applications
- Data Analysis
- Floors
- Notices
- Communication
- Brooklyn
- Business Alignment
- Evidence
- Strategic Planning
- Scientific
- Peer Reviews
- Checks
- Remediation
- Project
- Contractual Agreements
- PPAP
- Material Review Board
- Internal Audit
- Project Teams
- Packaging
- Policies and Procedures
- Regulations
- Recon
- International
- Business Units
- Purchasing
- Executive Management
- HEV
- Reviews
- Internal Customers
- Green Belt
- Bridge Inspection
- Electronics Technology
- Corrective and Preventive Action Capa
- Charter
- Compliance
- Product Lifecycle Management
- Mechanical Engineering
- Support Engineers
- Internal Controls
- Engineering Changes
- Tracks
- Kaizen
- Technical Issues
- Directions
- Meetings
- Supply Chain
- Templates
- Product Quality
- Failure Mode and Effects Analysis
- Statistical Process Control
- u.s. Food and Drug Administration
- Verification and Validation
- Corrective and Preventive Action
James Ledlum Summary
- James Ledlum, based in Minneapolis, MN, US, is currently a Vice President of Quality and Regulatory Operations at Covetrus. James Ledlum brings experience from previous roles at JammieOne LLC - Quality and Regulatory Solutions, Entegris and Insulet Corporation. James Ledlum holds a Masters in Technology Management (Specialty: Production Ops - Includes Quality Management & Strategic Planning) @ UW-Stout Polytechnic. With a robust skill set that includes FDA, ISO, Supplier Quality, Quality Auditing, GMP and more. James Ledlum has 1 emails and 4 mobile phone numbers on RocketReach.
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