Senior Quality Engineer in Digital Surgery R&D

Responsible for the Engineering Development Program (EDP) for Quality Engineering at Ethicon in Cincinnati. This includes recruiting, hiring and mentoring recent college hires as well as working with Quality Leadership across the Energy, Endo-mechanical and Robotics Franchises to develop rotational placement opportunities.

Primary Quality Engineer in Digital Surgery.

Systems Quality Engineer role. Responsible for ensuring synergy across all Enable Injections medical devices and ensures that Design Controls and Risk Management requirements are consistently employed and applied across all subsystems. Implementing systems to ensure that all Regulatory Requirements are integrated into the Enable Injections medical device design and the Quality Management Systems (e.g., Design Controls, Risk Management, and Statistical Analysis) are compliant. Conducts frequent and detailed quality checks of the Risk Management Files and Design History Files to make sure the products and processes are consistent and meet both industry and client standards as well as legal demands.

Developed a systems approach to create and maintain projects during product development and reduce the impact of maintenance post transfer during product life cycle. Design and implement test plans and audits for products to ensure product quality targets are met. Component Quality assurance including Incoming Inspection, Criticality assessment, Sample Size Selection, Inspection Method determination and Validation, Inspection Equipment Selection, qualification, and validation, Gage R&R Studies, First Article Inspection requirements determination. Final Inspection Method determination including Sampling Plans, Acceptance criteria, equipment selection, and Test Method Validation. Support Process/Product Validations through Sample Size determination, Normality Testing and Data Analysis. Establish Statistical Process Monitoring & Control in production. Support product development projects and teams as required. Support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program. Support trend analysis tools to report on operational performance, product quality and monitor the effectiveness of corrective actions related to deviations, internal audits, customer complaints, and supplier performance. Support material review board activities per control of non-conforming materials; Interface with suppliers to improve incoming quality issues.

Consultant with TATA Consultancy Services working in Product Quality Risk Management to align procedures and product documentation with FDA/EU/etc regulations and internal company standards (ISO 14971, ISO 13485, 21 CFR Part 820, etc.).Projects:Risk management quality engineering- Updated procedures to align with newly released standards. Revised FMEAs, risk reports, etc. for released products.Lifecycle quality engineering- Updated SOPs to aid with changes to internal systems. Performed statistical analyses for CAPA council reviews, gap analyses for standards/procedures, and risk assessments. Reviewed IQ/OQ/PQ documentation in manufacturing. Operated as SME for development and revision of FMEAs.NPD quality engineering- Advised teams as SME for internal risk management procedures and advised NPD teams of documentation requirements. Assisted in product reviews. Managed new hires and reviewed deliverables for quality assurance.Risk management and customer quality- Developed procedures for aligning risk documents and reporting policies and improved upon existing company forms. Trouble-shot proposed strategies and recommended alternative approaches. Managed and tracked the Offshore team's progress in documentation analysis. Trained associates in statistical analysis and risk management. TATA Ethicon Cincinnati team Learning Prime- Acted as the point of contact between onsite team members and HR. Suggested applicable training and classes to associates. Responsible for assembling team building activities.

Product manufacturing for a small business. I managed the production team and scheduling. I developed formulations in NPD, scaled up production capability and developed procedures regarding batch mixing and hygiene practices.

Worked as a co-op student at UC Metabolic Diseases Institute and as a student worker for the Transgenic Mouse Core, Department of Molecular Genetics and Cell Biology.