Sirisha Pannala

·15 Months work experience as a Quality Engineer in the development of products to ensure the highest level of product and process quality.

· Responsible for investigating and implementing robust corrective/preventive actions for process/device non-conformances; root cause analysis, monitoring complaint rates and initiated improvements where required;

· Worked on complaint handling for mobile CT scanner called AIRO.

· Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.

· Supported risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.

· Helped on FDA audit readiness on Quality Management System (QMS) per compliance, Review design control activities, DHF, Design reviews, CAPA remediation, Closed NCR's / CAPA to make sure each NC's and CAPA closure and effectiveness verified per CFR 21 Part 820 compliance, Supplier management files, Documentation system and Complaints files

· Experience in working with salesforce and trackwise tools.

· Utilized standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc