Danielle Ledsam Email & Phone Number
Director Of Quality @ Cora
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Danielle Ledsam Location
- Carmel Valley, CA, US
Danielle Ledsam Work
- 2021 -now Director Of Quality @
- 2020 -now CEO @ SouthCoast QMS Consulting Services
- 2012 -now QMS consultant @ SouthCoast QMS Consulting Services
- 2019 -2021 Director of Quality @
- 2014 -2015 Business Analyst I - Change Analyst @
- 2013 -2014 Quality Management Specialist @ WomenCare Global
- 2012 -2013 Quality Assurance and Compliance @ COVIDIEN RMS
- 2008 -2009 Document Control Coordinator @ MCKENNA LABS, INC
- 2006 -2007 Accounts Payable Specialist @ MCKENNA LABS, INC
- 1998 -2003 Office Manager and Accounts Payable Specialist @ LA FIESTA FOOD PRODUCTS, INC
Danielle Ledsam Education
- ASQ
CQM/OE Certification (CQM/OE Certification, Certified Quality Management/Operational Excellence)
2018-2025 - Oriel Stat a Matrix
EU MDR 2017/745 Implementation (EU MDR 2017/745 Implementation, Medical Device Regulations 2017/745)
2020-2020 - ASQ
CQA (CQA, Quality Auditing Medical Devices and Suppliers)
2019-2019 - University of California San Diego - School of Extended Studies and Public Programs
Clinical Trials Design & Management (Clinical Trials Design & Management, Pharmaceutical Clinical Trials/Medical Devices)
2015-2016 - ALLIANT INTERNATIONAL UNIVERSITY
MBA (MBA, Business)
2009-2012 - SAN JOSE STATE UNIVERSITY
Bachelor of Science (B.S.) (Bachelor of Science (B.S.), Behavioral Science and Psychology)
2001 - MBA, RAC, CMQ/OE, CQA, CMDA
Danielle Ledsam Skills
- Quality System
- GMP
- Medical Devices
- Quality Assurance
- Analysis
- Sustainability
- FDA
- Manufacturing
- Accounting
- Accounts Payable
- Project Coordination
- Office Management
- ISO 13485
- Accounts Receivable
- Financial Analysis
- General Ledger
- Risk Management
- Regulatory Requirements
- Process Improvement
- Business Process Improvement
- Sustainability Planning
- Office Administration
- Licensing
- ISO13485
- Regulatory Affairs
- Internal Audit
- Clinical Research
- Stakeholder Engagement
- RoHS
- Economic Research
- FDA GMP
- ASEAN
- CE marking
- Medical Device Directive
- Design History File (Medical Devices)
- Sustainability Strategy
- GRI Sustainability Reporter
- Natural Step
- Energy Tracking
- Product Foreign Registration
- Engineering Change Orders (DocContol)
- ISO14971
- GMP Audit
- GDP Audit
- Design History Report (Medical Devices)
- Product Development Design Controls
Danielle Ledsam Summary
- Danielle Ledsam, based in Carmel Valley, CA, US, is currently a Director Of Quality at Cora. Danielle Ledsam brings experience from previous roles at SouthCoast QMS Consulting Services, Zelegent and Advanced Sterilization Products (a Johnson & Johnson Company). Danielle Ledsam holds a 2018 - 2025 CQM/OE Certification in CQM/OE Certification, Certified Quality Management/Operational Excellence @ ASQ. With a robust skill set that includes Quality System, GMP, Medical Devices, Quality Assurance, Analysis and more. Danielle Ledsam has 3 emails and 1 mobile phone numbers on RocketReach.
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