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.
Required Skills and Experience :
5 years+ experience in a Laboratory environment.Manual Differential testing experienceExperience with new instrument validation / qualification as it relates to best practices for the IQ / OQ / PQ in the clinical labBachelor's Degree