Recording Engineer & Manager for commercial audio / video recording, mixing and Mastering.

Leading teams in optimizing the efficiency and effectiveness of Quality Systems supporting Medical Device. Military, and Telecommunication product development and commercialization initiatives.

Providing strategic and project execution FDA remediation support for Medical Device manufacturing, CLIA lab processes and HIPAA / HITRUST regulations.

Program Manager for launch of 6 proprietary container closure systems: • Controlled and facilitated establishing Requirements / Design Control documentation, Material Characterization / Qualification protocols, Test Method Development / Validation, Container Blow Fill Seal process Development / Validation, Visual Particulate inspection process implementation, Capital requests, vendor / customer engagement, Inspection readiness / CAPA investigations and Program Management documentation

Instructor for Lean Six Sigma Green / Black Belt training course. Training individuals across a variety of industries and improvement opportunities through Lean Six Sigma history, DMAIC process, Lean Six Sigma problem solving tools and statistical concepts. • Worked with students to understand Lean Six Sigma problem solving tools and how to apply improvement tools through the DMAIC process to achieve process improvement results.

Managed FDA Post Market Requirement submission update activities for USP 233 requirements placed on all Baxter products including testing method validations, product testing results, medical safety evaluations, product specification updates and product / process / supplier control updates.• Developed overall program plan / timeline accounting for all product file submission updates and product specification implementations over multiple years / program phases.• Coordinated executive… Show more Managed FDA Post Market Requirement submission update activities for USP 233 requirements placed on all Baxter products including testing method validations, product testing results, medical safety evaluations, product specification updates and product / process / supplier control updates.• Developed overall program plan / timeline accounting for all product file submission updates and product specification implementations over multiple years / program phases.• Coordinated executive status reporting from global multi-site cross functional sub teams.• Successfully managed delivery of 3 separate product subgroup Post Market Requirement publication submissions to FDA. Show less

Managed Baxter's global Lean Six Sigma Green Belt & Project Management training program; student scheduling, training material updates / publication, classroom administration, student testing / certification.• Developed and implemented integrated Lean Six Sigma and Project Management tools, templates and training materials.• Trained over 70 students on Lean Six Sigma & Project Management methods for the Green Belt Certification course.• Provided mentoring support for the training… Show more Managed Baxter's global Lean Six Sigma Green Belt & Project Management training program; student scheduling, training material updates / publication, classroom administration, student testing / certification.• Developed and implemented integrated Lean Six Sigma and Project Management tools, templates and training materials.• Trained over 70 students on Lean Six Sigma & Project Management methods for the Green Belt Certification course.• Provided mentoring support for the training students. Reviewed / approved DMAIC project documentation for certification requirements. Show less

Corporate Quality Project Manager assigned to deliver Quality System and Business Process improvements. • Corporate Quality Resource Management Process Implementation project: Developed andimplemented a $0 capital expense SharePoint / Excel resource forecasting system including employee time entry and leadership dashboards for project / operation resource allocation tracking covering 100+ employees across 5 functional areas. Created summary dashboards designed to provide organizational… Show more Corporate Quality Project Manager assigned to deliver Quality System and Business Process improvements. • Corporate Quality Resource Management Process Implementation project: Developed andimplemented a $0 capital expense SharePoint / Excel resource forecasting system including employee time entry and leadership dashboards for project / operation resource allocation tracking covering 100+ employees across 5 functional areas. Created summary dashboards designed to provide organizational resource loading summaries for strategic reallocation decisions.• Global Quality System policy harmonization / change deployment process improvement project: Led a global team to develop and implement a global Quality System policy change plan review and scheduling process at $0 capital expense. The system gathered scheduling / change feedback from over 100 plants worldwide using SharePoint tools reducing change cycle time by %75.• Quality System Improvement Planning process project: Developed and implemented a global Quality System employee usability survey to gather and summarize 1000+ global evaluations on policy effectiveness / usability leading to the identification / prioritization of policy improvement opportunities to support the Global Strategic Planning process.• Lean Six Sigma Black Belt Mentor: Provided Lean Six Sigma training and mentoring support for the global Lean Six Sigma training program students. Show less

Divisional Quality Project Manager assigned to deliver Quality System and Business Process improvements. • Strategic Planning Process Improvement project: Developed / implemented divisional Project Portfolio Management processes and methods using SharePoint for $0 capital expense.• Quality System Remediation Program: Led Field Action, Internal Audit, Management Review and CAPA departmental teams through mapping of regulatory requirements to Quality System/Business process procedures and… Show more Divisional Quality Project Manager assigned to deliver Quality System and Business Process improvements. • Strategic Planning Process Improvement project: Developed / implemented divisional Project Portfolio Management processes and methods using SharePoint for $0 capital expense.• Quality System Remediation Program: Led Field Action, Internal Audit, Management Review and CAPA departmental teams through mapping of regulatory requirements to Quality System/Business process procedures and deliverables, performing process FMEAs to identify improvement opportunities, and establishing Process Owner op mechs and process metrics for continuous improvement monitoring. • Global CAPA Process Improvement program: Managed multisite CAPA system improvement program serving over 1500 users. Developed global user feedback analysis identifying systemic issues related to process effectiveness monitoring, resource management and method/IT process alignment.• Served as Area Champion for Malcolm Baldrige and Shingo Business Excellence method deployment Initiative. Led divisional teams to implement functional area process maps to identify interdepartmental customer requirements, process measurements and improvement opportunities. Show less

Site Business Excellence Group Project Manager assigned to deliver Quality System and Business Process improvements. • Document Change Management Process Automation Project: Developed / implemented an automated document change management solution serving ~400 users and 10,000 changes/year• Project / Resource Portfolio Management System project: Developed / implemented process and CA Clarity automated solution for ~200 Project/Resource Managers, 800 team resources, covering 600+… Show more Site Business Excellence Group Project Manager assigned to deliver Quality System and Business Process improvements. • Document Change Management Process Automation Project: Developed / implemented an automated document change management solution serving ~400 users and 10,000 changes/year• Project / Resource Portfolio Management System project: Developed / implemented process and CA Clarity automated solution for ~200 Project/Resource Managers, 800 team resources, covering 600+ projects• Commercial Operations Call Center Value Stream Analysis project: Completed measurement system analysis of customer satisfaction measurement system that aligned improvement efforts to high value improvement opportunities. Developed call center value stream map process to improve complaint handing.• Lean Six Sigma Black Belt Mentor: Provide team facilitation and mentoring on Lean Six Sigma processes and tools.• Lean Six Sigma Instructor: Provide Project Portfolio Management / Sponsor training to 100+ mid /senior managers as part of a Lean Six Sigma deployment initiative. Show less

Quality Engineering Group Project Manager assigned to deliver Quality System and Business Process improvements. • Employee Guided Leadership system project: Developed process to provide a quantifiable continuous improvement measurement method for employee satisfaction, development, retention and improvement opportunities. Implemented the process in R&D Quality Engineering and R&D Quality organizations.• Performance Management Metrics Development process project: Completed internal voice… Show more Quality Engineering Group Project Manager assigned to deliver Quality System and Business Process improvements. • Employee Guided Leadership system project: Developed process to provide a quantifiable continuous improvement measurement method for employee satisfaction, development, retention and improvement opportunities. Implemented the process in R&D Quality Engineering and R&D Quality organizations.• Performance Management Metrics Development process project: Completed internal voice of customer analysis to identify root cause factors of ineffective Quality System metrics. Completed external industry leader benchmarking to identify best-in-class metrics development process. Developed and implemented new metrics development methods.• Statistical Process Control system implementation project: Completed development and implementation of a 21 CFR Part11 electronic record / signature compliant software system (InfinityQS). Developed streamlined CDRH compliant application validation process to provide fast implementation / modification of quality system application implementations. Show less

• Manage human resources (Headcount, performance appraisals, merit budget, etc.).• Responsible for compliance of personnel, facilities, equipment and control systems in order to meet GMP, FDA, ISO and OSHA requirements for manufacturing support and product development activities.• Maintain financial reporting system databases and department zero balance budget. Consolidate information from multiple sources and create monthly journal entry reports to cover department labor and material… Show more • Manage human resources (Headcount, performance appraisals, merit budget, etc.).• Responsible for compliance of personnel, facilities, equipment and control systems in order to meet GMP, FDA, ISO and OSHA requirements for manufacturing support and product development activities.• Maintain financial reporting system databases and department zero balance budget. Consolidate information from multiple sources and create monthly journal entry reports to cover department labor and material costs. Generate capital estimates for facility and equipment as needed.• Responsible for equipment validation protocol approval. Supported manufacturing process design for new products including experimental design efforts, analysis of DOE experimental results, and improvement proposals Show less

• Create / execute validations supporting rapid assay manufacturing equipment• Implemented CAPA system in the Pilot Plant environment to meet regulatory expectation for product release activities. Defined how the CAPA system applies the R&D / manufacturing support activities of the Pilot Plant. Developed and implemented Pilot Plant procedures to satisfy requirements of the global Quality System.• Integrated the MQA organization into the Pilot Plant work order process review / approve… Show more • Create / execute validations supporting rapid assay manufacturing equipment• Implemented CAPA system in the Pilot Plant environment to meet regulatory expectation for product release activities. Defined how the CAPA system applies the R&D / manufacturing support activities of the Pilot Plant. Developed and implemented Pilot Plant procedures to satisfy requirements of the global Quality System.• Integrated the MQA organization into the Pilot Plant work order process review / approve product support activities. Show less

• Created and executed equipment validations for Pilot equipment used in manufacturing Strep A OBC II and H.Pylori assays.• Developed new / troubleshot existing product designs and associated pilot manufacturing processes. Assessed assembly process capability and its effect on corresponding device performance.• Optimized the assembly and performance of disposable devices by characterizing the interaction between reagents, membrane materials and plastic components.• Accurately… Show more • Created and executed equipment validations for Pilot equipment used in manufacturing Strep A OBC II and H.Pylori assays.• Developed new / troubleshot existing product designs and associated pilot manufacturing processes. Assessed assembly process capability and its effect on corresponding device performance.• Optimized the assembly and performance of disposable devices by characterizing the interaction between reagents, membrane materials and plastic components.• Accurately summarized / interpreted experimental data and communicated results to engineers and scientists within various R&D, Device Development and Product Support Teams.• Developed and implemented a networked work order database system to track Pilot Plant workflow, work orders and corresponding interdepartmental charge-outs. Show less

• Supervise sixteen hourly personnel in aseptic filling of small volume parenterals. Completed annual appraisals and development plans.• Managed Propofol launch activities including: filling equipment upgrades, solution prep load cell installation, in-process ampule nitrogen headspace analyzer installation, all procedural / work order updates and first lots to stock productions runs.• Decreased documentation errors by 63% by improving work order documentation flow /… Show more • Supervise sixteen hourly personnel in aseptic filling of small volume parenterals. Completed annual appraisals and development plans.• Managed Propofol launch activities including: filling equipment upgrades, solution prep load cell installation, in-process ampule nitrogen headspace analyzer installation, all procedural / work order updates and first lots to stock productions runs.• Decreased documentation errors by 63% by improving work order documentation flow / clarity.• Redesigned work order document forms to support Multi tank filling process cost reduction with $200K realized annual savings.• Developed spray gun sanitization method reducing over action limit failures by 60% and annual material costs by $40K. Show less

• Supervise seven hourly personnel in commodity preparation processes for aseptic filling / lyophilization of small volume parenterals.• Provide support for the construction, modification or repair of equipment required for filling operations.• Troubleshoot autoclaves, dry heat ovens, and various vial washer control systems.• Created computerized tracking mechanism / database for purge cart Preventative Maintenance testing reducing 99 preventive maintenance requests to 1.