Responsible for New Product Development and Sustaining Quality for Instruments (Flow Cytometry/Cell Sorter/Sample Preparation), Software, Informatics, Assay/Reagents

Managed five direct reports and contributed to the Design Quality team for Class 2 Alinity h-series blood analyzer and CELL-DYN platform instruments. Collaborated with cross-functional teams, including Program Management, Software/System/Hardware Engineering, Reagents/Consumables Development, Regulatory, Commercial Marketing, Medical Affairs, Clinical, Product Quality, and On-Market Engineering. Handled design planning, design inputs/outputs, risk management, device master record, design transfer, and product launch activities. Supported audits, reported design quality metrics, oversaw HW/SW design changes, and provided quality support for design plan and DHF deliverables. Implemented design control training and led the Alinity h system project for US 510(k) submission. Received Core Diagnostics President’s Award in 2023.

Skills Highlighted:

Team Management

Cross-functional Collaboration

Design Planning

Risk Management

Audit Support

Quality Metrics Reporting

HW/SW Design Changes

Design Control Training

Project Leadership

Award Recognition

Managed seven direct reports and four temp personnel for quality systems, design assurance, and quality engineering activities for Class 3 disposable catheter and Class 2 controller devices. Handled CAPA, complaints management, and FDA submission preparation activities. Trained site personnel for audits, received EN ISO 13485 QMS and MDD (CE) certification, and St. Jude Pinnacle Award. Developed quality system, wrote procedures, and supported FDA IDE and 510K submissions. Acted as subject matter expert for design assurance, risk management, biocompatibility, and global compliance. Prepared master quality plan for site decommissioning and product transfer.

Skills Highlighted:

Team Management

Quality Systems

Design Assurance

Regulatory Compliance

Audit Training

Award Recognition

Managed DHFs, risk management files, and post-market surveillance activities, including technical files, quality planning, and annual product review. Supported global compliance activities, including complaint investigations, product list and application updates, design change notifications, annual CDRH laser reports, electrical safety testing, supplier audits, and compliance. Supported internal audits and front-room representative for notified body / FDA audits. Acted as project manager for ROHS implementation for RF, laser, IPL, and ultrasound energy product families consisting of 5K components. Provided QE support for multiple product families (design changes for ~20 projects)

Oversight of document control, QA / QC, supplier quality, design quality, and QMS for Class 3 obesity management device. Oversaw calibration and equipment maintenance processes, CAPA, document control / records management, quality engineering, and EH&S. Revised and released product returns SOPs, including explant return kit and servicing lifecycle SOP. Initiated Lunch-and-Learn quality training program for CAPA, compliance, risk management, and process validation. Managed 2012 BSI microbiology audit with zero non-conformances.