Summary Principal Quality Assurance Engineer with over 20 years of experience in both hardware and software quality engineering and compliance, with equal accomplishments in quality engineering and quality management. Extensive experience applying design controls to new product development of regulated class II Infusion and IVD medical device instrumentation, for electrical, mechanical, and embedded software driven medical devices integrated with software products. Experienced with infusion product development for the infusion system devices, software products, and infusion EMR interoperability. Performed variety of new and sustaining product development tasks, quality planning, design verification & validation, design reviews, risk management, and design transfer. Expertise in all aspects of Quality Assurance in product development, manufacturing operations, test laboratories, hardware & software processes in regulated environments. Experienced with regulated consumer products, commercial materials and processes. Proven organizational and team building skills.

Highlights:

• Complaints
• Instrumentation
• Integrate
• ISO
• ISO 9001
• Reliability
• Audit
• Chemistry
• Compliance
• Consumer Products