Elevate quality assurance with HepQuant as a Quality Engineer II in Denver, CO. Oversee processes ensuring compliance with FDA and ISO standards while enhancing In-Vitro Diagnostics.At HepQuant, you will hold a pivotal role in maintaining and improving the Quality Management System (QMS) for clinical diagnostics. With 3-5 years in quality engineering, you will execute validations, lead investigations into product quality issues, and ensure adherence to regulatory packaging.



Your work directly supports the assessment of liver health through innovative blood tests.Key Responsibilities:Develop and execute validation plans for IVD productsLead investigations into product complaints and non-conformancesEnsure compliance with ISO 13485 and cGMP regulationsConduct equipment qualification and software validation proceduresOversee supplier quality audits and risk assessmentsRequirements:Bachelor's in Engineering or Life Sciences3-5+ years in quality engineering or assuranceUnderstanding of FDA standards and ISO regulationsProficient in statistical analysis using MinitabCertification as ASQ Certified Quality Engineer preferredFocus your expertise on enhancing IVD quality and compliance in a team-oriented team environment at HepQuant.#J-18808-Ljbffr

📌 Quality Engineer Ii At Hepquant (Hastings County)
🏢 HepQuant
📍 Hastings County