Quality Engineer II at HepQuant

Location: Quinte West

Elevate quality assurance with Hep Quant as a Quality Engineer II in Denver, CO. Oversee processes ensuring compliance with FDA and ISO standards while enhancing In-Vitro Diagnostics.

At Hep Quant, 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 products

• Lead investigations into product complaints and non-conformances

• Ensure compliance with ISO 13485 and cGMP regulations

• Conduct equipment qualification and software validation procedures

• Oversee supplier quality audits and risk assessments

Requirements:

• Bachelor’s in Engineering or Life Sciences

• 3-5+ years in quality engineering or assurance

• Understanding of FDA standards and ISO regulations

• Proficient in statistical analysis using Minitab

• Certification as ASQ Certified Quality Engineer preferred

Focus your expertise on enhancing IVD quality and compliance in a collaborative team environment at Hep Quant.
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