Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrated communication, interpersonal, and problem solving skills. Ability to lead change and take on any challenge to meet company objectives.

Highlights:

• CAPA
• FDA
• ISO
• Complaints
• Auditor