Summary: The purpose of this position is to assist in the management of the validation activities mandated by medical device regulatory requirements (e.g. FDA, MDD, SFDA). The Validation Co-Op is responsible for assisting the validation leads and validation management with validation activities related to specific projects and validation process improvement. This happens at the portfolio-level, wherein multiple projects, each at a different phase of development, must be supported simultaneously. Key Areas of Responsibility: •Assist the validation lead by communicating in-process status of validation in a timely manner •Management of validation equipment and tools •Troubleshooting and reporting of issues into problem report management system (defect management) •Responsible for assisting with execution of validation protocols. •Responsible for writing or assisting with validation document deliverables at the discretion of the project validation lead. •Participate in or lead process activities as assigned •Provide feedback to the team regarding needed process improvements •Awareness of timelines and deliverables for all validation projects •Serviceability validation dry runs •Independent audit of validation test cases (clinical, service, etc) •Data management Minimum Qualifications: • Enrolled in a Bachelor's program in an Engineering field or equivalent • Proficient with Microsoft XP & Office (Word, Excel, Project, etc.) • Good written, oral, & interpersonal skills • Advanced troubleshooting & problem solving skills
A little about us:
We partner with people to improve skills, teams and lives every day, and we help them achieve more than they ever thought possible.