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.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
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
Benefit packages for this role will start on the 31st 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.