Responsible for overall Quality System and commercialization support.

Manage over 40 Engineers, Inspectors and Technicians supporting Quality manufacturing of catheter-based Mitral Valve device. Support non-conformances, process improvement, tools/equipment and variety of quality compliance oversight activities. Currently lead Supplier Quality Engineering and Receiving Inspection for all components and services from supplier evaluations on risk and capability, component specifications and receiving inspection test methods.

Support sustaining quality in manufacturing. Mentor and support Quality Engineers and other cross functional employees.

• Coordinated software testing with software managers.• Coordinated software verification and validation (V&V) activities.• Participated in code reviews and code walkthroughs.• Participated in review and development of product, design and functional requirements and specifications.• Managed development of software V&V test plans, protocols, and verification and validation test data & reports.• Evaluated requirements for testability and test cases for efficiency.• Established and maintained Project Management processes (PMPs).• Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.• Coordinated testing outlined in protocols and test methods. • Performed process improvement, control and monitoring on manufacturing processes.• Provided technical direction during design transfer activities. • Conducted complaint investigations.• Participated in project planning, budgeting, scheduling and tracking.• Developed and implemented procedures to comply with corporate, industry and regulatory standards.

•Managed team of business systems analysts to execute country-wide system consolidation project.•Produced project plans, status updates, business cases, requirements documents, resource plans.•Managed business outsourcing project for membership group leading to planned $700K annual savings.

Installed Base Leader, Complaints Leader, Program Integrator•Supervised a core team of 5 engineers and an extended team of 10 cross-functional representatives.•Executed and ensured continuous process improvement of global complaint handling procedure.•Program Manager for software and hardware maintenance releases from design and implementation.•Coordinated analysis of product quality including trend analysis, reporting and action planning.•Expert resource on complaints and regulations during internal and external audits.•Led Risk Management team for product safety complaints.•Managed engineering resources for problem root cause investigation and CAPA.•Led planning and implementation of corrections and corrective actions for customer issues.•Program Integrator for planning and implementation of field modifications to meet FDA obligations.•Lead integrator for installed base issues between service, engineering, operations, manufacturing.•Monitored of FOI, FOA, IFR, MFR and remanufacture issues out of manufacturing.•Managed 15 major software/hardware release projects.•Led process redesigns resulting in over 10% reduction of warranty costs year over year.•Saved over $500,000 in direct labor costs through continuous improvements and process changes.

•Managed verification and validation of multiple medical monitoring products.•Developed user and system V&V requirements and tests.•Managed testing resources - products, lab, testers.•Provided quality engineering support and advice for software development.•Coordinated regression, integration and other various levels of testing monitoring software.•Developer of internal software automation architecture, tools and tests.