Director of Software Development at PTC - Responsible for leading the team that built the Windchill Quality Management Solutions
-CEM (Customer Experience Management)
-CAPA (Corrective Action/Preventive Action)
Thorough understanding of Medical Device/Life Sciences and FDA Regulations and Validation including FDA 21 CFR Part 820; FDA 21 CFR Part 11 electronic records/signatures, and electronic submissions.
Excellence in several high profile projects involving regulatory management system development and implementation.
Hands-on experience and knowledge of Product Lifecycle Management (PLM).
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- Thingworx IoT Certified Developer
- Implemented a connected medical device solution offering remote service and maintenance for a Fortune 500 Medical Device Manufacturer.
- Implementation of enterprise quality complaint management system for a $14B Medical Device Manufacturer.
- Implementation and configuration of enterprise quality management system, CAPA, Nonconformance, Complaints, Audit and Field Action for a $2B Medical Device Manufacturer.
- Implementation and configuration of a CAPA and Nonconformance solution for a $8B Medical Device Manufacturer.
- Design and development of business database solution for a $34B Telecommunications company.