Quality Engineer

Louisville, KY, United States of America

At Whip Mix, innovation isn’t just what we do—it’s who we are. For over a century, we’ve been a trusted partner to dental professionals worldwide. From designing and manufacturing cutting-edge digital solutions to tried-and-true lab essentials, we bring craftsmanship, technology, and customer care together in one place.

We’re proud to be a family-owned, Louisville-based company with a global reach, serving dental labs, universities, and clinicians across more than 80 countries. Our mission? To combine quality and creativity with a service-first mindset that makes a real difference in people’s lives. If you’re looking to join a team where tradition meets innovation, and where every day brings new opportunities to grow, Whip Mix is the place for you.

We are looking for a Quality Engineer to join our team! You'll play a key role in maintaining compliance, advancing product development, and ensuring regulatory readiness.

What you'll be doing:

• Partner with product design and development teams to ensure products are safe, effective, and customer focused.
• Create and maintain Design & Development documentation in alignment with ISO 13485, cGMP, MDR, and MDSAP standards.
• Design, validate, and monitor manufacturing processes for medical and non-medical products.
• Coordinate 510(k) submissions, CE Mark applications, and ensure technical documentation meets ISO and regulatory standards.
• Lead external quality audits (FDA, ISO, customer) and prepare compliance documentation.
• Perform risk assessments, capability analyses, and statistical data trending to validate designs and processes.
• Support root cause investigations, corrective/preventive actions (CAPAs), and quality improvement initiatives.
• Develop quality plans for incoming and outsourced materials/products.

What you'll bring to the table:

• Bachelor's degree in engineering or related field
• Advanced training related to QMS disciplines
• Auditor and QE certifications are preferred
• 5+ years of experience managing/developing a QMS that meets FDA and ISO 13485 requirements preferred
• Experience in process validation, CAPA activities and productions non-conformances required

BA/BS Enginnering or Science

This job reports to the Meena Muniaswamy