Example Experience: : Minimum of six (6) years of experience as a Quality and/or Compliance professional working in the FDA or in regulated industry (i.e. Medical Device, Pharmaceutical, Biotechnology, etc.), or as a Consultant..Bachelors or Masters level of education, or equivalent experience preferred. Must be proficient with writing and presentations skills. The ability to travel both domestic and internationally is a major aspect of the role.
Example Responsibilities: Team Auditor, Consultant, or Technical Advisor working in a FDA regulated environment. Work solo or on teams performing remediation or providing tactical consultation in response to FDA Actions (FDA-483s and Warning Letters). Experience working on large or complex projects with multiple work streams. Experience in reviewing Device Quality System and/or Drug GMP documentation to ensure compliance with FDA and ISO Requirements Sub-team lead of one or more project teams is desired.
Technical Experience: Experience in at least one of the following areas: Complaint Handling and Post Market Reporting, Production & Process Controls (including Process Validation), Design Controls, Risk Management, CAPA, Computer System Validation,, Purchasing & Supplier Controls, Management Controls, Recalls and Training.