Insight Global is looking for a strong CAPA Quality Engineer to join a leading health technology manufacturing company sitting 100% remote. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing relationships with approval agencies such as the US Federal Drug Administration (FDA). Triage and root cause investigation of newly opened CAPA Requests. Work with Subject Matter Experts and Element Owners as needed to gather information and investigate issues. Gathering data from many systems for analysis. Triage completed investigations for CAPA Review Board. Independently produces and completes CAPA records. Ability to assess risk as it pertains to the CAPA. Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving. Represent CAPAs during audits and CAPA Review Board meetings. Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement. This is a remote 12-month long contract role, with potential for extension or conversion.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.