Regulatory submissions and technical file reviews globally. Coordinating and executing Class II medical device summative usability studies.Authoring regulatory, clinical, and usability documents (Clinical Evaluation Plans and Reports; Usability Investigation Plans and Reports; Post-Market Surveillance Plans, Reports and Follow-up Plans; Summary Technical Documentation, General Safety and Performance; Managing MDR conversion projects (both new and existing products), including generating all Summary Technical Documents (STED) files and General Safety and Performance. UDI; Labeling and Testing Validation.Developing Regulatory and Clinical document templates for the Quality Management System (QMS). (CFR 21 Labeling; EPA Regulated Products; UDI Work Instructions ect…) Generating Clinical Equivalence Rationale and Non-significant Change Determination documents for non-significant changes (FDA). Clinical study start-up, and study conduct activities.Creating Training materials and training on new and updated regulations, processes and other required training sessions. Managing Risk Management 2019 updates with Engineering and Quality Departments (Risk Management Plans and Reports, Master Validation Plans and Reports, IQ/OQ/PQ).Managed Smarter Sorting Platform, SMETA for Medical Device audits.

Control all Quality Documents for entire company including: Procedures, Technical Work Instructions, Forms/Logs, Production Inspection Cards, SDS SheetsGather and display Quality data including: Travel, Vacation, Training, MRB, Audits, CAR History BooksVisioPower PointWordExcelPDFSAPSecuriSync

Directed business development of laser production (CNC laser cutting, welding and annealing) through customer requirements. Managed daily production operation and quality assurance. • Implemented continuous improvement projects on production cycle times.• Created Quality Assurance documentation for full production cycle.• Assisted in restructuring company website to redirect market emphasis.

Biological Science ResearchField Experience in soil science and botanySoil analysisSeed Bank studiesMorphology

Developed and guided full documentation through multiple phases of manufacturing, for XF96/24 and XFe96/24 Analyzers. Managed continuous improvement & process optimization projects for lean manufacturing goal of lowering production times and increasing value stream for customers. • Created & maintained technical and test instruction documents for two R&D instruments entering into and two currently in production.• Created & managed MSDS database.• Lead continuous improvement projects on production cycle times.• Managed multiple R & D projects.• Assisted in production room optimization (Lean methodologies including critical path analysis. Kanban system, JiT, Kaizen among others).• Training of mechanical & electro-mechanical processes.

Regulatory & Compliance Documentation

Contributed heavily with the development/transition of MicroCal’s world’s most sensitive heat detecting scientific instruments from R&D into Production. • Created technical documents for R&D instruments entering into Production.• Lead continuous improvement projects on production cycle times.• Training of mechanical & electro-mechanical processes.• Trade Show & Customer Relations• Microscopic assembly of thermopile wires, uses of epoxies, silicones, soldering, circuitry and electronics

Managed ten full time employees along with departmental set-up and maintenance. Created and maintained production schedules and continuous improvement efforts. Conducted sales negotiations with client facing relationships through trade shows and conferences. Spearheaded cycle time studies to decrease production times and optimize manufacturing processes per departmental goal of lowering cycle times by 0.15%. • Spearheaded continuous improvement projects on production cycle times, decreased times by 0.33% - 0.25%.• Lead continuous improvement projects.• Training of mechanical processes.

Managed a team of five employees. Created and maintained production schedules and all departmental set up. Guided process optimization for increased piecework numbers and product development. Research and presented new product information in client facing meetings, sales negotiations and trade shows. • Implemented continuous improvement projects on process optimization.• Lead employee meetings