Required Skills & Experience
- 5 years+ experience in a Laboratory environment.
- Manual Differential testing experience
- Experience with new instrument validation / qualification as it relates to best practices for the IQ / OQ / PQ in the clinical lab -Bachelors Degree
Job Description
IG is seeking lab specialist that will be focused on supporting the development and validation of innovative in-vitro diagnostic (IVD) devices. This position plays a key role in ensuring product safety, performance, and regulatory compliance, while collaborating across departments to drive innovation. -Support the design, testing, and reporting of new or updated IVD devices.
Operate and maintain a variety of lab instruments and platforms.Lead and manage clinical studies and complaint investigations.Conduct Clinical Software Validations (CSV) and instrument qualification (IQ / OQ / PQ)Apply quality and regulatory standards (GLP, GCP, ISO) to lab processes.Troubleshoot technical issues using scientific judgment.Work cross-functionally with teams in manufacturing, marketing, quality, and regulatory.