Experienced Quality Assurance Consultants with a demonstrated experience in leading quality teams and excellent problem solving skills. Working knowledge of 21CFR Part 820, ISO 13485 and regulations associated with software development lifecycle. Audit experience is beneficial along with experience in GCPs, GLPs and/or GMPs.

Responsibilities include conducting quality audits and developing subsequent preventive and corrective actions plans (CAPA); interfacing with clients to achieve desired results; and translating applicable regulatory requirements into processes/procedures that meet the intent of organizational requirements, applicable regulations, and ISO Standards.